ISSN 1949-8241 • E-ISSN 1949-825X Volume 18, Numbers 2-3
Outcomes and
Advances in
Assistive
Technologies for
Rehabilitation
Transtibial Economic Evaluations 85
Review of Amputee Gait Training 99
Residual Limb Ulcer Management 115
Volume 18 • Numbers 2-3 Pages 83-225 Technology and Innovation 2016 National Academy of Inventors
for Leg Amputees
EDITORS-IN-CHIEF
PAUL R. SANBERG ERIC R. FOSSUM
University of South Florida Dartmouth College
Tampa, FL Hanover, NH
SENIOR EDITORS
HOWARD J. FEDEROFF NASSER ARSHADI
University of California, Irvine University of Missouri – Saint Louis
Irvine, CA St. Louis, MO
EDITORIAL STAFF
Judy Lowry, Managing Editor Kimberly Macuare, Assistant Editor
EDITORIAL BOARD
Shantikumar Nair, Amrita University, India Steven J. Kubisen, The George Washington University
Sethuraman Panchanathan, Arizona State University Jarett Rieger, H. Lee Moffitt Cancer Center & Research
Institute
David Winwood, Association of University Technology
Managers Christopher Fasel, Idaho State University
Jay Gogue, Auburn University Sharon Heise, Institute for Human & Machine Cognition
Rivka Carmi, Ben-Gurion University of the Negev, Israel A. Alan Moghissi, Institute for Regulatory Science
Ernest B. Izevbigie, Benson Idahosa University, Nigeria Cama McNamara, Inventor’s Digest
Mark Rudin, Boise State University Ken S. Lee, Jackson State University
Gloria Waters, Boston University Christy Wyskiel, Johns Hopkins University
Farnam Jahanian, Carnegie Mellon University Solomon H. Snyder, Johns Hopkins University
Joseph Jankowski, Case Western Reserve University Mary Rezac, Kansas State University
Shinn-Zong (John) Lin, China Medical University, Taiwan Paul DiCorleto, Kent State University
Todd Headley, Colorado State University Norman R. Augustine, Lockheed Martin Corporation
Scot Hamilton, Columbia University Kalliat T. Valsaraj, Louisiana State University
Alice Li, Cornell University Richard Kordal, Louisiana Tech University
Donna M. DeCarolis, Drexel University Robert S. Langer, Massachusetts Institute of Technology
Marti Van Scott, East Carolina University Rebecca Mahurin, Montana State University
Todd Sherer, Emory University Vimal Chaitanya, New Mexico State University
John W. Newcomer, Florida Atlantic University Kurt H. Becker, New York University
Tachung (T.C.) Yih, Florida Gulf Coast University Lesley Rigg, Northern Illinois University
Tristan J. Fiedler, Florida Institute of Technology James G. Conley, Northwestern University
Andres G. Gil, Florida International University Arlene A. Garrison, Oak Ridge Associated Universities
Lawrence O. Gostin, Georgetown University Law Center Lonnie G. Thompson, The Ohio State University
John J. Kopchick, Ohio University Karen J.L. Burg, University of Georgia
Steven Price, Oklahoma State University Derek E. Eberhart, University of Georgia
Neil A. Sharkey, The Pennsylvania State University Richard C. Willson, University of Houston
Curtis R. Carlson, The Practice of Innovation Lesley Millar-Nicholson, University of Illinois at
Urbana-Champaign
Kenneth J. Blank, Rowan University
Taunya Phillips Walker, University of Kentucky
S. David Kimball, Rutgers, The State University of
New Jersey Mary Shire, University of Limerick, Ireland
Raymond C. Tait, Saint Louis University William M. Pierce, Jr., University of Louisville
Arthur Molella, Smithsonian Lemelson Center Patrick O’Shea, University of Maryland
Arthur J. Tipton, Southern Research Institute Louis A. Carpino, University of Massachusetts – Amherst
Christos Christodoulatos, Stevens Institute of Technology James P. McNamara, University of Massachusetts Medical
School
Robert V. Duncan, Texas Tech University
Kenneth J. Nisbet, University of Michigan
Stephen Klasko, Thomas Jefferson University
Henry C. Foley, University of Missouri – Columbia
Richard A. Houghten, Torrey Pines Institute for Molecular
Studies Lawrence Dreyfus, University of Missouri – Kansas City
Woody Maggard, University at Buffalo – State University of Prem S. Paul, University of Nebraska-Lincoln
New York
Zachary Miles, The University of Nevada, Las Vegas
Stephen Z. Cheng, The University of Akron
Kumi Nagamoto-Combs, The University of North Dakota
Richard P. Swatloski, The University of Alabama
John Kantner, University of North Florida
Richard B. Marchase, The University of Alabama at
Birmingham Thomas McCoy, University of North Texas
James H. Bratton, The University of Oklahoma
Frederic Zenhausern, The University of Arizona
Lynne U. Chronister, The University of South Alabama
Jim Rankin, University of Arkansas
Linda P. B. Katehi, University of California, Davis Judy Genshaft, University of South Florida
Gordon C. Cannon, University of Southern Mississippi
M. J. Soileau, University of Central Florida
T. Taylor Eighmy, The University of Tennessee, Knoxville
Patrick A. Limbach, University of Cincinnati
Thomas Parks, The University of Utah
Inge Wefes, University of Colorado – Denver/AMC
William Barker, University of Wisconsin – Madison
Jeff Seemann, University of Connecticut
Mathew Willenbrink, University of Dayton H. Holden Thorp, Washington University in St. Louis
Keith H. Pickus, Wichita State University
David S. Weir, University of Delaware
Robert E. W. Fyffe, Wright State University
Paula Heldt, University of Evansville
T. Kyle Vanderlick, Yale University
David P. Norton, University of Florida
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Cover Photo: Eric Schroeder | Thinkstock.com
ISSN 1949-8241
Volume 18, Numbers 2-3, 2016 Pages 83 –225 E-ISSN 1949-825X
CONTENTS
SPECIAL TOPIC ISSUE: OUTCOMES AND ADVANCES IN ASSISTIVE TECHNOLOGIES
FOR REHABILITATION
Outcomes and Advances in Assistive Technologies for Rehabilitation: Special Topic Edition 83
Overview
M. Jason Highsmith
Economic Evaluations of Interventions for Transtibial Amputees: A Scoping Review of 85
Comparative Studies
M. Jason Highsmith, Jason T. Kahle, Amanda Lewandowski, Tyler D. Klenow,
John J. Orriola, Rebecca M. Miro, Owen T. Hill, Sylvia Ursula Raschke,
Michael. S. Orendurff, James T. Highsmith, and Bryce S. Sutton
Gait Training Interventions for Lower Extremity Amputees: A Systematic Literature Review 99
M. Jason Highsmith, Casey R. Andrews, Claire Millman, Ashley Fuller, Jason T. Kahle,
Tyler D. Klenow, Katherine L. Lewis, Rachel C. Bradley, and John J. Orriola
Interventions to Manage Residual Limb Ulceration Due to Prosthetic Use in Individuals 115
with Lower Extremity Amputation: A Systematic Review of the Literature
M. Jason Highsmith, Jason T. Kahle, Tyler D. Klenow, Casey R. Andrews,
Katherine L. Lewis, Rachel C. Bradley, Jessica M. Ward, John J. Orriola, and
James T. Highsmith
Predicting Walking Ability Following Lower Limb Amputation: An Updated Systematic 125
Literature Review
Jason T. Kahle, M. Jason Highsmith, Hans Schaepper, Anton Johannesson,
Michael S. Orendurff, and Kenton Kaufman
Effects of the Genium Knee System on Functional Level, Stair Ambulation, Perceptive and 139
Economic Outcomes in Transfemoral Amputees
M. Jason Highsmith, Jason T. Kahle, Matthew M. Wernke, Stephanie L. Carey,
Rebecca M. Miro, Derek J. Lura, and Bryce S. Sutton
Effects of the Genium Microprocessor Knee System on Knee Moment Symmetry during 151
Hill Walking
M. Jason Highsmith, Tyler D. Klenow, Jason T. Kahle, Matthew M. Werke,
Stephanie L. Carey, Rebecca M. Miro, and Derek J. Lura
Bioenergetic Differences during Walking and Running in Transfemoral Amputee Runners 159
Using Articulating and Non-Articulating Knee Prostheses
M. Jason Highsmith, Jason T. Kahle, Rebecca M. Miro, and Larry J. Mengelkoch
The Effect of Transfemoral Interface Design on Gait Speed and Risk of Falls 167
Jason T. Kahle, Tyler D. Klenow, William J. Sampson, and M. Jason Highsmith
Comparative Effectiveness of an Adjustable Transfemoral Prosthetic Interface Accomodating 175
Volume Fluctuation: Case Study
Jason T. Kahle, Tyler D. Klenow, and M. Jason Highsmith
Concurrent Validity of the Continuous Scale-Physical Functional Performance-10 (CS-PFP-10) 185
Test in Transfemoral Amputees
M. Jason Highsmith, Jason T. Kahle, Rebecca M. Miro, M. Elaine Cress,
William S. Quillen, Stephanie L. Carey, Rajiv V. Dubey, and Larry J. Mengelkoch
Psychometric Evaluation of the Hill Assessment Index (HAI) and Stair Assessment Index (SAI) 193
in High-Functioning Transfemoral Amputees
M. Jason Highsmith, Jason T. Kahle, Brain Kaluf, Rebecca M. Miro,
Larry J. Mengelkoch, and Tyler D. Klenow
Biopsy 1-2-3 in Dermatologic Surgery: Improving Smartphone Use to Avoid Wrong-Site 203
Surgery
James T. Highsmith, David A. Weinstein, M. Jason Highsmith, and Jeremy R. Etzkorn
PLAY Hands Protective Gloves: Technical Note on Design and Concept 207
Michele Houston-Hicks, Derek J. Lura, and M. Jason Highsmith
Radiographic Assessment of Extremity Osseointegration for the Amputee 211
Munjed Al Muderis, Belinda A. Bosley, Anthony V. Florschutz, Paul A. Lunseth,
Tyler D. Klenow, M. Jason Highsmith, and Jason T. Kahle
REGULAR FEATURES
Taking Aim at Cancer 217
James Higgins and Alex Camarota
The NAI Profile: An Interview with Dr. Robert S. Langer 219
Robert S. Langer and Kimberly A. Macuare
Aims and Scopes i
Preparation of Manuscripts ii
Ethics Statement ii
www.technologyandinnovation.org
Technology and Innovation, Vol. 18, pp. 83-84, 2016 ISSN 1949-8241 • E-ISSN 1949-825X
Printed in the USA. All rights reserved. http://dx.doi.org/10.21300/18.2-3.2016.83
Copyright © 2016 National Academy of Inventors. www.technologyandinnovation.org
OUTCOMES AND ADVANCES IN ASSISTIVE TECHNOLOGIES
FOR REHABILITATION: SPECIAL TOPIC EDITION OVERVIEW
M. Jason Highsmith 1-3
1 School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, FL, USA
2 Extremity Trauma & Amputation Center of Excellence (EACE), U.S. Department of Veterans Affairs, Tampa, FL, USA
3 319 Minimal Care Detachment, U.S. Army Reserves, Pinellas Park, FL, USA
th
Once again, the National Academy of Inventors (www.academyofinventors.org), a nonprofit organization
recognizing and encouraging creativity and invention, is pleased to present scientific findings in the areas of
prosthetics, orthotics, and assistive technologies from researchers representing the University of South Florida’s
(USF) School of Physical Therapy & Rehabilitation Sciences (SPTRS), the Extremity Trauma & Amputation
Center of Excellence (EACE), and numerous colleagues and collaborators in the U.S. and abroad. The NAI
continues to grow its reach with new national and international academic and institutional partnerships.
This special topic edition of Technology and Innovation, Journal of the National Academy of Inventors will
predominantly feature prosthetic and amputee rehabilitation related topics. It also includes other assistive
technology, therapeutic, and surgical topics with high clinical relevance from clinician scientists. This edition
is timely in the wake of recent significant challenges with health care reimbursement. Specifically, third-party
payors of health care services, citing limited quality and quantity of evidence regarding interventions pro-
vided by rehabilitation clinicians who care for patients with limb loss who use prostheses, have attempted to
restructure reimbursement practices and policies. As a result, professional organizations within the prosthetic
and orthotic professions, including the American Academy of Orthotists and Prosthetists and the American
Orthotic & Prosthetic Association among others, formulated a multi-pronged response to defend the merit of
the interventions provided by these professionals. Domains represented in the responses from these organiza-
tions included advocacy and research. Some of the products of these efforts are contained within this edition.
Specific study designs contained in this issue represent a considerable portion of the evidence pyramid,
including systematic reviews, clinical research, case reports, outcomes research, and technical notes. From a
funding perspective, numerous sponsors deserve acknowledgment for facilitating production of this research
and the associated knowledge products. For instance, the USF SPTRS, the state of Florida, industry sponsors,
professional organizations, and the National Institutes of Health, by way of a Scholars in Patient Oriented
Research (SPOR) grant, were among the research sponsors.
Highlights from a content perspective include an economic analysis of transtibial interventions and system-
atic reviews on dermatologic issues, gait training, and walking function in persons with lower limb amputation.
Additionally, several intervention pieces evaluate comparative efficacy of prosthetic socket and knee interven-
_____________________
Accepted July 1, 2016.
Address correspondence to M. Jason Highsmith, Extremity Trauma & Amputation Center of Excellence (EACE), 8900 Grand Oak Circle (151R), Tampa, FL
33637-1022, USA. Tel: +1 (813) 558-3936; Fax: +1 (813) 558-3990; E-mail: [email protected]
83
84 HIGHSMITH
tions. New concepts are considered in select assistive technologies and surgical domains. Finally, much needed
psychometric work is presented in clinical outcome measures used in the evaluation of those using artificial
limb technologies.
Those who contributed to the science and dissemination of this research hope that consumers, payors,
clinicians, academicians, and, above all, patients will benefit from the findings contained in this edition of
Technology and Innovation. It is hoped that the findings will continue to build the body of knowledge within
the rehabilitation sciences, including prosthetics and orthotics. It is further hoped that this science will assist
in the reimbursement arena with clinical decision making and that others will build on and expand on these
findings to continue to push the boundaries of what can be achieved for those who use assistive technologies.
Technology and Innovation, Vol. 18, pp. 85-98, 2016 ISSN 1949-8241 • E-ISSN 1949-825X
Printed in the USA. All rights reserved. http://dx.doi.org/10.21300/18.2-3.2016.85
Copyright © 2016 National Academy of Inventors. www.technologyandinnovation.org
ECONOMIC EVALUATIONS OF INTERVENTIONS
FOR TRANSTIBIAL AMPUTEES:
A SCOPING REVIEW OF COMPARATIVE STUDIES
M. Jason Highsmith , Jason T. Kahle , Amanda Lewandowski , Tyler D. Klenow ,
6
4,5
1-3
7
John J. Orriola , Rebecca M. Miro , Owen T. Hill , Sylvia Ursula Raschke ,
1
8
10
9
Michael S. Orendurff , James T. Highsmith 12,13 , and Bryce S. Sutton 14
11
1 School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, FL, USA
2 Extremity Trauma & Amputation Center of Excellence (EACE), U.S. Department of Veterans Affairs, Tampa, FL, USA
3 319 Minimal Care Detachment, U.S. Army Reserves, Pinellas Park, FL, USA
th
4 OP Solutions, Tampa, FL, USA
5 Prosthetic Design + Research, Tampa, FL, USA
6 Select Physical Therapy, Brandon, FL, USA
7 Prosthetics and Sensory Aids Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
8 Shimberg Health Sciences Library, University of South Florida, Tampa, FL, USA
9 Extremity Trauma & Amputation Center of Excellence (EACE), San Antonio Medical Center, Fort Sam Houston, TX, USA
10 Center for Rehabilitation Engineering and Technology that Enables (CREATE), BCIT Technology Centre, Burnaby, Canada
11 Motion & Sports Performance Laboratory, Lucile Packard Children’s Hospital Stanford, Palo Alto, CA, USA
12 Dermatology Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
13 Dermatology Surgery Institute, Lutz, FL, USA
14 Center of Innovation on Disability and Rehabilitation Research (CINDRR-TPA), James A. Haley Veterans’ Hospital, Tampa, FL, USA
Transtibial amputation (TTA) is life-altering emotionally, functionally, and economically. The
economic impact to all stakeholders is largely unknown, as is the cost-effectiveness of prosthetic
intervention. This scoping report’s purpose was to determine if there is sufficient evidence to
conduct a formal systematic review or meta-analysis in any particular prosthetic intervention
area and to determine if any evidence statements could be synthesized relative to economic
evaluation of interventions provided to patients with TTA. The scoping review revealed six
articles representing three topical areas of transtibial care: Care Models, Prosthetic Treatment,
and Prosthetic Sockets. All six articles were cost-identification or cost-consequence design
and included a total of 704 subjects. Presently, it can be concluded with moderate confidence
that specific weight-bearing and total-contact sockets for transtibial amputees are functionally
and economically equivalent in the short term when costs, delivery time, and all stakeholder
perspectives are considered. Long-term socket outcomes are relatively unexplored. Further
primary research is needed beyond this to determine cost-effectiveness for other areas of tran-
stibial prosthetic care although clinical outcomes are somewhat established through systematic
review and meta-analysis in other areas of care. Conversely, evaluation of narrative economic
reports relative to transtibial care may be sufficient to warrant further analysis. Guidance from
the profession may also be useful in devising a strategy for how to assure economic analyses
are a routine element of future prosthetic science.
Key words: Cost-benefit; Cost-consequence; Cost-effectiveness; Cost utility; Cost identification;
Health economics; Prosthetic socket
_____________________
Accepted July 1, 2016.
Address correspondence to M. Jason Highsmith, Extremity Trauma & Amputation Center of Excellence (EACE), 8900 Grand Oak Circle (151R), Tampa, FL
33637-1022, USA. Tel: +1 (813) 558-3936; Fax: +1 (813) 558-3990; E-mail: [email protected]
1-8585
86 HIGHSMITH ET AL.
INTRODUCTION outcomes (i.e., fewer emergency room admissions
Persons with transtibial amputation (TTA) 1.6 vs. 2.1; p < 0.05) (11). Prosthetic users were more
commonly use prostheses to ambulate. Prosthetic likely to receive outpatient therapy compared with
provision is a considerable health care expense over non-prosthetic users (27.2 more visits; p < 0.05).
the lifetime for TTA patients. Estimated lifetime pros- Physical therapy participation was associated with
thetic costs for an individual with unilateral lower fewer acute care hospitalizations and less facili-
limb amputation could range from $0.5 to $1.8 mil- ty-based care (p < 0.05), which offsets the initial high
lion depending on many factors, such as the number cost associated with prosthetic provision. In other
and type of prostheses in service at a given time (1). words, the higher initial costs decrease the burden
Collectively, care for the amputee of dysvascular eti- on the health care system by decreasing utilization
ology has societal costs (U.S.) of an estimated $4.3 and adverse events. This cost savings provides insight
billion, and Medicare reimbursed $655 million worth into costs not paid (i.e., resources saved) as a result of
of lower limb prosthetic services in 2009 (2,3). proper rehabilitative care including prosthetic provi-
Given the numerous intervention options and sion. This savings might be considered value. These
costs associated with amputee rehabilitation and pros- data (11) further suggest the prosthesis was nearly
thetic provision, it is problematic that the literature’s amortized at 12 months, and users may experience
ability to guide clinical practice, reimbursement, or higher quality of life and increased independence
health care policy is limited. For example, promi- compared to non-prosthetic users.
nent reviews on the subjects of foot prescription (4) Given the recent reimbursement challenges based
and post-operative management (5) indicate that no on a lack of clinical and economic evidence, there is
clinical recommendations can be made due to a lack a need to understand and document the cost-effec-
of evidence. Within the prosthetic profession, this is tiveness of prosthetic rehabilitation for TTA patients.
problematic given the 2012 report by the U.S. Office of Therefore, this project’s purpose was to conduct a sys-
the Inspector General indicating ≈$4.7 million worth tematic scoping review of the literature to determine if
of Medicare billings were inappropriate (2). Moreover, clinical sub-topics had sufficient evidence for further
some insurers impose a one-limb-per-lifetime reim- systematic review and meta-analysis. Additionally,
bursement limit, further substantiating the need for the review sought to formulate evidence statements
economic data related to TTA prosthetic care (6). related to prosthetic interventions for persons with
Another consideration is that TTA patients develop TTA from an economic evaluation perspective based
secondary conditions related to sound limb overuse, solely on comparative studies.
prosthetic malalignment, and other factors, includ-
ing degenerative joint disease, osteopenia, postural METHODS
issues, low back pain, and others (7). Each of these On the assumption that economic evaluations for
secondary complications has health care utilization TTA prosthetic interventions would be limited, inves-
and cost implications that are unexplored with regard tigators opted for an inclusive search considering any
to this population. Nevertheless, many TTA patients element of the prosthesis (foot, ankle, pylon, socket,
lead functional lifestyles (8), at times participating liner, suspension) as well as complete prosthetic care.
in sport and athletic pursuits (9). Incorporation of a On November 18, 2015, three databases—MEDLINE
prosthesis is routinely part of the rehabilitation and (Pubmed), The Cumulative Index to Nursing and
reintegration plan (10). Allied Health Literature (CINAHL) (Ovid), and the
A 2013 analysis of Medicare beneficiaries (2008 Cochrane Database of Systematic Reviews—were
Jan 1 to 2009 Jun 30) with recent lower limb ampu- systematically searched for combinations of the fol-
tation reported that, compared to non-prosthetic lowing primary search terms:
users, those who received prostheses had compara-
ble Medicare episode payments (including prosthetic
costs: $68,040 vs. $67,312; p > 0.05) and superior
TRANSTIBIAL ECONOMIC EVALUATIONS 87
(prosthe* OR “Prostheses and Implants” OR for classification as: 1) pertinent, 2) not pertinent,
prosthesis OR prostheses OR preprosthe* or 3) uncertain pertinence. Full-text articles were
OR pre-prosthe*) reviewed for citations classified as pertinent or uncer-
AND tain pertinence. Disagreement regarding citations of
(((transtibial OR trans-tibial OR trans tibial OR uncertain pertinence were resolved by discussion with
below knee OR bka OR tta OR Leg[Mesh] OR leg a third rater. Review of full-text articles and associ-
OR legs OR lower limb OR lower limbs OR lower ated discussion led to group consensus and ultimate
extremity OR lower extremit* inclusion/exclusion. The following inclusion criteria
OR “Lower Extremity”[Mesh]))) were applied to studies (12):
Primary search terms were combined systematically 1. Included a clinical intervention comparison
with the following secondary search terms: for patients with TTA
2. Included any one of the following types of eco-
Cost OR Econ* OR Efficacy OR “Cost Benefit”
OR “Cost Effectiveness” OR “Cost Utility” nomic evaluation:
a. Cost-consequence analysis (CCA), involv-
OR “Healthcare Econ*”
ing a way of reporting cost and an array of
The following date limits were implemented as part of outcomes in a separate and disaggregated
the database search parameters: 1997 Jan 1 through way so that no incremental ratios are
2015 Nov 15. involved
b. Cost-effectiveness analysis (CEA), involving
Article Screening incremental analysis between the calculated
Resulting references were exported to EndNote differences in costs and outcomes
(vX6, Thompson, CA, USA) reference management c. Cost-benefit analysis (CBA), which values
software, where Stage 1 screening was applied. Stage both measured health and non-health out-
1 screening, including a title and abstract review and comes in monetary units
the elimination of duplicate references, was applied. d. Cost-utility analysis (CUA), involving util-
Remaining economic evaluation articles were sorted ities, quality-adjusted life years (QALY), or
by topic. Exclusion criteria were applied starting at their variants as the measured outcomes
Stage 1 to eliminate studies that merely describe costs e. Cost-identification analysis (CIA), in which
but otherwise lack cost comparison. Foreign lan- a cost comparison is made without the inclu-
guage articles were eliminated because of prohibitive sion of a comparison of health outcomes
translation fees. Economic evaluation articles from 3. Published within the aforementioned timeline
developing nations were excluded due to an inability
to apply their findings to the U.S. health care market. Data Extraction
Articles were screened for exclusion using the follow- Data were extracted and categorized according to
ing criteria within EndNote: country origin, economic evaluation analysis design
(trial- or modeling-design), economic evaluation type
1. Foreign language (i.e., non-English language) (CCA, CEA, CBA, CUA, or CIA as defined above),
2. Developing countries perspective, time horizon, intervention and follow-up
3. Any study lacking an economic evaluation or period, study population, alternatives compared,
cost-comparison analysis
4. Retrospective studies costs, and outcomes. Reported costs were converted
to U.S. dollars by dividing the local currency unit
5. Case studies
with the purchasing power parity rates for the men-
Following Stage 1 screening, Stage 2 screening was tioned price year and subsequently inflated to 2016
applied as outlined here. Remaining economic evalua- year dollars as defined by the World Bank Group
tion articles were reviewed by two raters and screened (13,14). If the price-year was not stated in the study,
independently to verify inclusion/exclusion and the publication year was used. Final costs displayed
88 HIGHSMITH ET AL.
were rounded to the nearest whole number. If pos- quality of included studies was rated as described
sible, data were evaluated as appropriate for pooled below.
analyses.
Evaluation of Internal and External Validity
Sorting by Topic Methodological quality of included publications
Following screening for eligibility determination was independently assessed by two reviewers accord-
and data extraction, articles were sorted for perti- ing to the American Academy of Orthotists and
nence into available intervention topical areas. Prosthetists (AAOP) State-of-the-Science Evidence
Report Guidelines protocol (20). The AAOP Study
Quality Assessment Design Classification Scale was used to describe the
Economic Evaluation Quality design type of the included studies (20). The State of
the Science Conference (SSC) Quality Assessment
Each manuscript was assessed for its economic Form was used to rate the methodological quality
evaluation quality by two reviewers using the Quality of studies classified as experimental (E1 to E5) or
of Health Economic Studies (QHES) instrument and observational (O1 to O6) (20). The form identifies
the per-item scores averaged (15). In its original 18 potential threats to internal validity, with the first
form, QHES has 16 weighted criteria scored (scaled four threats not applicable for study classifications
1 to 100). Full weight is awarded for a ‘yes’ and no E3 to E5 and the first five threats not applicable for
weight for a ‘no’ response per criterion. Weights are classifications O1 to O6. Threats were evaluated and
relative to the per-criterion importance. This better tabulated. The internal and external validity of each
discriminates between poor and good quality eco- study was then subjectively rated as “high,” “moder-
nomic evaluations and is suitable for both trial- and ate,” or “low” based on the quantity and importance
modeling-based evaluation (16). QHES has good of threats present. For internal validity, 0 to 3 threats
reliability (17) and construct validity (18) and is a was rated “high,” 4 to 6 threats as “moderate,” and
commonly used tool (16,17,19). Its major limitation is 7 to 13 or 14 threats as “low.” For external validity,
its multi-topic items in a single criterion (i.e., multiple the form identifies eight threats. For this study, 0 to
items within a single item share a single weight). For 2 threats to external validity was rated “high,” 3 to 5
this review, the QHES scoring system was modified threats as “moderate,” and 6 to 8 threats as “low.” Each
without changing the original weights to overcome study was then given an overall quality of evidence of
this drawback in accordance with previous use (12). “high,” “moderate,” and “low” outlined by the AAOP
Multi-topic questions were assigned sub-weights per State-of-the-Science Evidence Report Guidelines (20).
item but still summed to the original weight. Items 12 The overall ratings from the QHES and from
and 13 were modified to rate both trial- and model- the AAOP State-of-the-Science Evidence Report
ing-based economic evaluation. Item 6 was modified Guidelines were used in assigning confidence to the
to enable the ability to rate CBA evaluations; however, developed empirical evidence statements described
it was still not applicable to CCA. Thus, the total base in following section.
score was 94 for CCA evaluations. The score of item
4 did not count when it was not applicable, but the Empirical Evidence Statements
total score remained 100 since its weight was small
and only negligibly affected the overall score. Based on results from the included publications,
After determining the total scores and converting empirical evidence statements (EES) were devel-
to a percentage, a total QHES score of 75 to 100 indi- oped that compared TTA interventions economically.
cated “high quality,” 50 to 74 indicated “fair quality,” Reviewers rated the level of confidence of each EES as
25 to 49 indicated “poor quality,” and 0 to 24 indicated “high,” “moderate,” “low,” or “insufficient” based on
“extremely poor quality” (12). Following the rating the number of publications contributing to the state-
for economic evaluation with QHES, methodological ment, the methodological quality of those studies,
TRANSTIBIAL ECONOMIC EVALUATIONS 89
Figure 1. Flow diagram.
Articles identified through database searching:
Identification PubMed, CINAHL, Google Scholar Articles Eliminated
(n=292)
Stage 1 Screening
Articles potentially avaialble (n=263)
Screening (n=29) Articles Eliminated
for classification of pertinence
Stage 2 Screening
(n=23)
Eligibility for Soring & Evaluation
Articles deemed appropriate
(n=6)
Included Care Models Treatment (n=2) Prosthetic Sockets
Prosthetic
(n=1)
(n=3)
and whether the contributing findings were confir- these, only two of the studies were funded, one by
matory or conflicting as similarly outlined by others multiple sources (professional association, govern-
(21). mental, educational) (23) and the other by an insurer
(26).
RESULTS
Study Demographics, Interventions, and
Literature Search Outcome Measures
The search yielded 292 manuscripts (Figure 1).
Stage 1 screening eliminated 263 manuscripts and Articles in this review included a total of 704
stage 2 screening an additional 23 manuscripts, leav- patients. Among them, 460 were undergoing limb
ing six articles meeting eligibility criteria. The six salvage, whereas the remaining 244 had TTA of mixed
remaining articles, published from 2004 to 2011, etiology. The median (range) sample size was n =
were divided into the following three topical areas: 43 (20 to 484). See Table 1 for extracted study data,
including specific characteristics of the subjects and
1. Care Models (n = 1) (22) studies. The reviewed studies were classified into
2. Prosthetic Treatment (n = 2) (23,24) three of the 15 potential study designs (controlled
3. Prosthetic Sockets (n = 3) (25-27) trial, randomized controlled trial, and case-con-
Three of the articles were published in Prosthetics and trol designs) described by the AAOP Study Design
Orthotics International. The remaining three papers Classification Scale (20). All three of the socket manu-
were published in other journals. From an economic scripts represented experimental study designs, while
evaluation type, all six papers were trial-design (as the remaining three utilized observational designs.
opposed to modeling). Five were cost-consequence Clinical outcome measures reported in the reviewed
evaluations and one was a cost-identification design publications included duration of care, perceived
(Table 1). function, prosthetic satisfaction, clinical gait out-
comes, time to prosthetic delivery, and number of
Funding visits. Economic outcomes reported in the reviewed
Four of the six manuscripts included a statement publications included cost of prosthetic fabrica-
disclosing whether or not the study was funded. Of tion, prosthetic maintenance, prosthetic provision,
90 HIGHSMITH ET AL.
Outcomes Public sector patients perceived function & prosthetic satisfaction increased & labor costs 10-29% lower (p < 0.05). TTA + care (surgery-2 y follow- up including prosthesis) $4,928 more costly vs. LS. LS + care (surgery thru 1 y + hospitalizations, device provision, therapy) $97,076 more vs. TTA. PTB socket provision cost 60% less than HSD. PTB pr
Follow-up Period Interim to definitive fit (d): 112 vs. 119 (p = 0.6) A Hospitalization: 17.9 d (LS) vs. 17.4d (TTA) A 1 y B 6 wks 3 mos 17 d (Plaster); 1 d (Direct mfg)
Interventions & Costs § (Standard vs. Comparator) Avg Labor Cost/Patient Public Sector: $1,466 Private Sector: $2,020 TTA + Care (including prosthesis): $90,875 LS + Associated Care: $85,682 TTA + Care (including prosthesis): $147,375 LS + Associated Care: $247,589 PTB socket: $477 HSD socket: $1,232 PTB socket: $1,045 TSB socket: $1,743 Plaster C
Age † 63 20- 45 y* ≈55 y 52 y 68 y; 58 y 66 y; 69 y patella tendon bearing socket. TSB is total surface bearing socket. LS is limb salvage.
Etiology 78% PVD, 22% other Trauma DM + Obese + CF vs. TTA 7 PVD; 10 Trauma; 4 other 14 PVD; 11 Trauma; 1 Cancer 12 PVD; 7 Trauma; 1 Infection
Table 1. Extracted Data Table 1. Extracted Data Author. Topic. n Country Year Care Gordon et 60 Models. al. Australia 2010 384 LS; Mackenzie Prosthetic 100 et al. Treatment. TTA U.S. 2007‡ Prosthetic 76 CF; Gil et al. Treatment. 17 TTA U.S. 2010 Prosthetic Datta et al. 21 Sockets. England 2004
TRANSTIBIAL ECONOMIC EVALUATIONS 91
amputation or limb reconstruction surgical costs,
and total care costs.
QHES Rating QHES Rating 64.0 (Fair Quality) 64.0 (Fair Quality) 77.0 (High Quality) 77.0 (High Quality) 62.5 (Fair Quality) 62.5 (Fair Quality) 69.0 (Fair Quality) 69.0 (Fair Quality) 57.5 (Fair Quality) 57.5 (Fair Quality) 65.5 (Fair Quality) 65.5 (Fair Quality) Economic Study Quality
All six studies were trial designs, so there were no
modeling designs. All included studies represented
the perspective of the provider, facility, and system
with only the exception of the Datta et al. (25) study,
which included elements from the patient perspec-
tive (e.g., travel considerations). Time horizon was
External External Validity Validity High High High High High High High High High High High High reported in the Care Model (two years) and Prosthetic
Treatment papers (40 months to two years). No time
horizon was reported in the Prosthetic Socket papers.
Conversely, follow-up periods were reported or dis-
Internal Internal Validity Validity High High Low Low Low Low Mod Mod Mod Mod Mod Mod cernable in every case. Criteria 5 (statistical and
sensitivity analyses) and 6 (incremental cost compar-
ison) were the least included criteria of the involved
studies. Normann et al. (27) was the only study that
included methods to address uncertainty, which was
Study Design Study Design Case Control Case Control Case Control‡ Case Control‡ Case Control Case Control Randomized Controlled Trial Randomized Controlled Trial Randomized Controlled Trial Randomized Controlled Trial Controlled Trial Controlled Trial QHES is Quality of Health Economic Studies. ‡Mackenzie et al. used a cost-identification design whereas al
of incremental analyses between alternative inter-
ventions was not done in any of the included studies
(i.e., all were cost-identification or cost-consequence
trial designs). Generally, positive attributes of the
studies included clear and measurable presentation
of objectives, use of detailed methodology for data
extraction, and appropriate utilization of primary
outcome measures. Other positive attributes of the
included studies included the use of reliable and well
justified measures, the measurement of appropriate
Author Author Year Gordon et al.(22) Gordon et al.(22) 2010 Mackenzie et al. (23) Mackenzie et al. (23) 2007 Gil et al. (24) Gil et al. (24) 2010 Datta et al. (25) Datta et al. (25) 2004 Selles et al. (26) Selles et al. (26) 2005 Normann et al. (27) Normann et al. (27) 2011 costs, the inclusion of descriptions of assumptions and
study limitations, and conclusions that were generally
based on study results. Overall, five of the studies were
rated as fair quality. The remaining paper, Mackenzie
et al. (23), was rated as high quality according to the
QHES (Table 2).
Table 2. Study Quality Ratings Table 2. Study Quality Ratings Table 2. Study Quality Ratings Year Topic Topic 2010 Care Models Care Models 2007 Prosthetic Treatment t Prosthetic Treatmen 2010 Prosthetic Treatment t Prosthetic Treatmen 2004 Prosthetic Sockets Prosthetic Sockets 2005 Prosthetic Sockets Prosthetic Sockets 2011 Prosthetic Sockets Pr
Threats to internal validity included lack of
blinding, not addressing fatigue and learning, and
not reporting effect size. Areas needing improvement
for internal validity were issues with attrition and sta-
tistical analyses. Use of robust outcome measures was
among the stronger criteria bolstering internal valid-
ity. Two studies had low, three had moderate level,
and one study had high internal validity. Conversely,
92 HIGHSMITH ET AL.
all of the studies had high external validity according newer socket regardless of which design it was. Also
to the AAOP rating tool. Bias risk from a research within the Prosthetic Socket Topic was a compari-
funding perspective was low given the majority of son of a direct fabrication technique compared with
studies were unfunded. traditional plaster casting methods. The direct man-
ufacturing method was associated with 32% higher
Economic Data provision costs (p < 0.01) but had the benefit of 58%
Key cost comparisons and outcomes are extracted faster delivery (p < 0.01) and 1.5 fewer visits.
into Table 1. Regarding Care Models, the average
labor cost per patient was 27% less costly in the pub- Evidence Statements
lic sector and was coupled with an improvement (p Five EESs (Table 3) were synthesized from the
< 0.001) in patient satisfaction relative to the private results within the three topical areas previously iden-
sector care model. tified. Four of the statements were supported by a
For Prosthetic Treatment, when limb salvage was single study resulting in an insufficient level of con-
the comparator, two different studies yielded mixed fidence. One statement from the Prosthetic Socket
results. Mackenzie et al. reported no practical differ- topical area had two studies with moderate and fair
ence in length of hospital stay between all average quality, respectively, from their validity and economic
limb salvage scenarios (17.9 days) and TTA (17.4 assessment, resulting in moderate confidence in the
days). However, their analysis concluded that two- statement from both the clinical science and eco-
year costs were 6% higher ($4,928) for TTA versus nomic perspectives.
limb salvage. Importantly, the nature of the limb
trauma and type of limb salvage procedure are fac- DISCUSSION
tors, and, in some limb salvage situations, two-year One purpose of this scoping review was to formu-
costs may be as much as 5% higher than TTA. In a late evidence statements and determine cost efficacy
study of those with Charcot foot and other comor- using economic evaluations of interventions pro-
bidities, one-year total care costs (i.e., hospitalization, vided to patients with TTA. Three topical areas, Care
device) were compared between those undergoing Models, Prosthetic Treatment, and Prosthetic Sockets,
limb salvage versus TTA. In this specific population, were identified, yielding synthesis of five evidence
the limb salvage surgery and the total cost of care, statements. The first statement addresses public ver-
including hospitalization, device provision, therapy, sus private care models at the point in care when an
etc., were reportedly more costly with limb salvage interim prosthesis is utilized by patients (22). Under
than TTA. The average cost increase for limb salvage the public model, a prosthetist was employed to pro-
was $7,461 or a 13% increase even with the added vide prostheses, whereas patients were referred out
expense of the prosthesis for the TTA cases. to external private practice prosthetists for artifi-
Three studies supported the Prosthetic Socket cial limb provision under the private care model.
topic. Two of the studies compared specific weight- Briefly, clinical outcomes were determined to be sim-
bearing (PTB) sockets with forms of total-contact ilar between the models, yet patient satisfaction was
sockets (hydrostatic design (HSD) and total surface higher and costs were approximately 29% lower per
bearing (TSB)). Both studies conclude that provi- patient when care was received from the public sec-
sion costs of PTB sockets are 60% (p < 0.01) of those tor compared with the private sector care model. In
of total-contact alternatives. The tradeoff for the this case, payors received the added value of cost sav-
reduced provision costs associated with PTB sock- ings in addition to higher patient satisfaction with
ets are increased provision time (three-fold increase; comparable clinical outcomes. The evidence state-
p < 0.05) and more visits (p < 0.05) necessary to ment is supported by a single study that has high
achieve a proper fit. Clinical outcomes were similar internal and external validity and fair quality as rated
between socket designs and preference was for the by the QHES (Tables 2 and 3), thus providing high
TRANSTIBIAL ECONOMIC EVALUATIONS 93
Table 3. Empirical Evidence Statements
Table 3. Empirical Evidence Statements
Supporting
Category Empirical Evidence Statement (EES)
Studies
(EES 1) In socialized healthcare systems, patients
with unilateral transtibial amputation may experience
similar clinical outcomes from the interim to definitive
Care Models prosthetic stages of rehabilitation with lower average High/Fair(22)
per-patient labor costs and higher satisfaction when
managed in a public sector care model compared with
a private sector care model.
(EES 2) Patients having experienced lower limb
trauma requiring limb salvage or transtibial
amputation will likely experience similar
hospitalization duration regardless of the choice of
Prosthetic surgical procedure. However, the two-year costs, on Moderate/High
Treatment average, will be approximately 6% higher for TTA (23)
versus limb salvage. In some situations, the limb
trauma and type of limb salvage procedure can
necessitate up to 5% higher costs compared with
TTA.
(EES 3) Patients with Charcot foot arthropathy and
multiple comorbidities will likely experience up to 13%
Prosthetic increased one-year costs (including hospitalization, Moderate/Fair
Treatment (24)
device provision, therapy) if limb salvage is selected
as opposed to transtibial amputation.
(EES 4) Provision of patella tendon bearing (PTB)
sockets for patients with transtibial amputation costs
Prosthetic 40% less than total contact socket alternatives Moderate/Fair
Two studies
Sockets however PTB sockets require up to three-times longer
to achieve a proper fit with no clinical performance (25,26)
differences between the alternatives.
(EES 5) Compared with traditional plaster casting
fabrication, the direct manufacturing method of
Prosthetic providing prosthetic sockets for patients with Moderate/Fair
Sockets transtibial amputation have 32% higher provision (27)
costs but are delivered to patients up to 58% faster
and in fewer visits.
Supporting Studies rated by AAOP tool/QHES. The Level of Confidence for EESs 1-3
and 5 is Insufficient based on limited evidence (i.e. a single study per topic). The fourth
statement (EES 4) is supported by sufficient evidence to support a Moderate level of
confidence in the statement.
94 HIGHSMITH ET AL.
confidence in the clinical outcomes and moderate statement and the fact that costs differ depending
confidence in the economic analysis. However, despite upon so many factors. Further, both amputation and
generally favorable scientific and economic quality limb salvage result in neuromusculoskeletal deficit,
ratings from a single study, this is insufficient to sup- which can lead to pain and loss of strength, power
port the statement until further studies can confirm generation, range of motion, and sensation. These
the findings. Another consideration for this state- impairments can impact function and quality of life.
ment is that the study represents the single country Clinical outcomes following amputation have been
of Australia. While other countries have socialized compared to those following limb salvage (29). A
medical models, various nations’ approaches to the definitive advantage to either has not been identi-
provision of socialized health care differ considerably. fied (30-33). This further confirms the autonomy
For comparison, the Veterans Affairs Amputation that practitioners must have when discussing options
System of Care (VA ASoC) is a U.S. government (i.e., with patients facing this decision due to an inability
public) sector health care system charged with provid- to empirically identify clear functional or economic
ing care for the unique population of military service advantages related to either decision given currently
Veterans with limb loss (28). The VA ASoC’s mission available data.
differs considerably from socialized models charged Also within the Prosthetic Treatment topic, EES 3,
with care provision for an entire country’s popula- which addresses patients with Charcot foot arthrop-
tion, and there is no clear private sector alternative to athy and multiple comorbidities such as diabetes and
compare outcomes within the U.S. Therefore, further obesity, was synthesized. In this study, patients report-
study is needed to determine if results of this study edly experienced up to 13% increased one-year costs
(22) are repeatable in other nations or sectors. (including hospitalization, device provision, and ther-
The second topical area was Prosthetic Treatment. apy) if limb salvage was selected as opposed to TTA.
This topical area yielded two EESs. Both statements This is a different clinical situation than that described
compared limb salvage with TTA. Factors included in EES 2 due to the etiology and comorbidities of the
were surgical costs, device provision, and associ- respective patients. The statement is supported by
ated costs. The first statement involved patients who a single study that has low internal and high exter-
experienced lower limb trauma requiring either limb nal validity and fair quality as rated by the QHES.
salvage or TTA. Their hospitalization times were sim- Clinical outcomes were not reported. Therefore, evi-
ilar regardless of the choice of surgical procedure. dence supporting this statement is also insufficient
However, the average two-year costs were 6% higher due to a lack of data to confirm support. Unlike the
for those undergoing TTA compared to those under- previous scenario, in which trauma drives the deci-
going limb salvage. This higher cost of TTA with sion to surgically salvage or amputate, authors in this
associated care is not always the case. For instance, study unanimously report increased cost associated
in some limb salvage situations, the extent of the limb with limb salvage in the obese diabetic patient with
trauma and type of limb salvage procedure can neces- Charcot arthropathy. This warrants further consider-
sitate up to 5% higher costs compared with TTA (23). ation, as obesity has not been shown to significantly
This EES is supported by a single study that has low impair ambulation or prognosis with a prosthesis
internal and high external validity and high quality as (34).
rated by the QHES, thus providing moderate confi- Prosthetic Sockets represent the third topical area
dence in the clinical outcomes and high confidence in in the review. This topic also resulted in the synthe-
the economic analysis. Nevertheless, the single study sis of two evidence statements. The first statement
supporting this statement has disagreement within in this topic (EES 4) states that provision of specific
it about costs relative to the specific levels of ampu- weight-bearing PTB sockets for patients with TTA
tation and certain types of limb salvage procedures. cost 40% less than total-contact socket alternatives.
Therefore, additional evidence is needed to support However, PTB sockets require up to three times longer
this EES given that only a single study supports the to achieve a proper fit with no clinical performance
TRANSTIBIAL ECONOMIC EVALUATIONS 95
differences among the alternatives. Therefore, accord- It is rated as fair quality according to the QHES. This
ing to the included studies (25,26), there is no cost evidentiary support provides moderate confidence in
reduction or clinical performance difference between the clinical outcomes and fair confidence in the eco-
the interventions. Although the PTB sockets have a nomic analysis. Again, further studies are needed to
lower initial cost, the additional clinic visits, which strengthen confidence in EES 5. Additionally, authors
require increased time commitments and travel costs were unable to locate data to support widespread
as well as the risk of potential complications, ulti- adoption of direct manufacturing techniques for TTA
mately increase latent costs. Conversely, provision socket provision.
of the more costly (initial cost) total-contact alter- A second purpose of this scoping review was to
native sockets results in fewer of these additional determine if further review and analysis is indicated
expenses and visits. Thus, the interventions appear based on the current state of the economic science
to be economically equivalent when viewed from all relative to care for the patient with TTA. It seems that
stakeholder perspectives in the short term. This fourth further analysis of economic comparison studies is
EES is supported by two studies, both with moderate less of an issue compared with the need for further
internal validity and high external validity (25,26). primary economic comparison research, input, and
Both are rated as fair quality studies according to the guidance from the profession relative to a strategy to
QHES. This evidentiary support provides moderate further develop this area of research. Additionally,
confidence in the clinical outcomes and fair confi- multiple manuscripts were excluded from this analysis
dence in the economic analysis. In contrast to these of economic comparisons that alternatively provide
studies, a recent systematic review suggests that use of descriptive economic information relative to care
gel-lined sockets, as opposed to traditional PTB sock- for persons with TTA. These excluded narrative eco-
ets, results in numerous clinical benefits, including nomic papers merit further review and analysis and
decreased walk aid dependence, improved suspen- are currently being evaluated by the authors.
sion options, improved load distribution, decreased
pain, and increased comfort (35). This systematic Limitations
review of clinical studies suggests gel-lined sockets
offer clinical improvements relative to PTB sockets Many subjects in this report were patients of limb
and is supported by Level 1 evidence. Thus, if clini- salvage procedures selected for comparison to TTA
cal outcomes are improved with total-contact sockets, cases. Unfortunately, many individual aspects of tran-
users may realize greater value through their use rel- stibial prosthetic intervention are not represented or
ative to PTB alternatives. This particular topic and are under-represented in the health care economic lit-
EES also point out the importance of considering all erature. Currently, economic evaluations in any area
perspectives in an economic analysis. A limitation of of transtibial patient care are limited. There were no
this EES is the time horizon. It is unclear if there are cost-benefit, cost-effectiveness, or cost-utility analyses
potential functional or cost differences over the long identified in this search, as all available studies were
term between specific weight-bearing and total-con- cost-identification or cost-consequence studies. No
tact socket alternatives. economic modeling was identified. Further, described
The second statement (EES 5) within the Prosthetic services and interventions were not quantifiably
Socket topic addresses traditional plaster casting connected directly to health measures. Therefore,
fabrication with direct manufacturing methods of more sophisticated and comprehensive economic
providing prosthetic sockets for patients with TTA. evaluations are needed with regard to transtibial inter-
Direct fabrication methods of socket delivery report- ventions to better understand the potential value of
edly have 32% higher initial provision costs but are certain interventions for the patient with TTA. One
delivered to patients up to 58% faster and in fewer possible solution is to incorporate outcomes condu-
visits. This EES is supported by a single study with cive to economic analysis and modeling as part of
moderate internal validity and high external validity. prosthetic oriented clinical trials (35). While total
96 HIGHSMITH ET AL. TRANSTIBIAL ECONOMIC EVALUATIONS 97
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no conflicts of interest. This project was funded by the Amputees and sports: a systematic review. Sports Schwartz JA. Assessment of the quality of cost Swiontkowski MF, Kellam JF, Smith DG, Sanders
Med. 2011;41(9):721-740. analysis literature in physical therapy. Phys Ther. RW, Jones AL, Starr AJ, McAndrew MP, Patterson
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Technology and Innovation, Vol. 18, pp. 99-113, 2016 ISSN 1949-8241 • E-ISSN 1949-825X
Printed in the USA. All rights reserved. http://dx.doi.org/10.21300/18.2-3.2016.99
Copyright © 2016 National Academy of Inventors. www.technologyandinnovation.org
GAIT TRAINING INTERVENTIONS FOR LOWER EXTREMITY
AMPUTEES: A SYSTEMATIC LITERATURE REVIEW
1,4
5,6
M. Jason Highsmith , Casey R. Andrews , Claire Millman , Ashley Fuller , Jason T. Kahle ,
1
1-3
1
7
1
4
Tyler D. Klenow , Katherine L. Lewis , Rachel C. Bradley , and John J. Orriola 8
1 School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, FL, USA
2 Extremity Trauma & Amputation Center of Excellence (EACE), U.S. Department of Veterans Affairs, Tampa, FL, USA
3 319 Minimal Care Detachment, U.S. Army Reserves, Pinellas Park, FL, USA
th
4 Physical Medicine & Rehabilitation Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
5 OP Solutions, Tampa, FL, USA
6 Prosthetic Design + Research, Tampa, FL, USA
7 Prosthetics and Sensory Aids Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
8 Shimberg Health Sciences Library, University of South Florida, Tampa, FL, USA
Lower extremity (LE) amputation patients who use prostheses have gait asymmetries and altered
limb loading and movement strategies when ambulating. Subsequent secondary conditions are
believed to be associated with gait deviations and lead to long-term complications that impact
function and quality of life as a result. The purpose of this study was to systematically review
the literature to determine the strength of evidence supporting gait training interventions and
to formulate evidence statements to guide practice and research related to therapeutic gait
training for lower extremity amputees. A systematic review of three databases was conducted
followed by evaluation of evidence and synthesis of empirical evidence statements (EES). Eigh-
teen manuscripts were included in the review, which covered two areas of gait training inter-
ventions: 1) overground and 2) treadmill-based. Eight EESs were synthesized. Four addressed
overground gait training, one covered treadmill training, and three statements addressed both
forms of therapy. Due to the gait asymmetries, altered biomechanics, and related secondary
consequences associated with LE amputation, gait training interventions are needed along
with study of their efficacy. Overground training with verbal or other auditory, manual, and
psychological awareness interventions was found to be effective at improving gait. Similarly,
treadmill-based training was found to be effective: 1) as a supplement to overground training;
2) independently when augmented with visual feedback and/or body weight support; or 3) as
part of a home exercise plan. Gait training approaches studied improved multiple areas of gait,
including sagittal and coronal biomechanics, spatiotemporal measures, and distance walked.
Key words: Amputee; Physical therapy; Prosthesis; Rehabilitation; Therapeutic exercise; Trans-
femoral; Transtibial; Treadmill
_____________________
Accepted July 1, 2016.
Address correspondence to M. Jason Highsmith, Extremity Trauma & Amputation Center of Excellence (EACE), 8900 Grand Oak Circle (151R), Tampa, FL
33637-1022, USA. Tel: +1 (813) 558-3936; Fax: +1 (813) 558-3990; E-mail: [email protected]
99
100 HIGHSMITH ET AL.
INTRODUCTION impaired (7,11). Gait patterns of LE amputees may
In 2005, there were 1.6 million Americans with also include lateral trunk flexion toward the prosthetic
limb amputation(s) (1-3). Annually, 185,000 people side secondary to weak hip abductors or decreased
experience upper or lower extremity (LE) limb loss for balance caused by socket instability and discomfort.
many reasons, including diabetic and vascular com- Moreover, the TFA gait pattern may also include
plications, trauma, and malignancy (1). Lower limb vaulting to assure prosthetic limb clearance during
amputations represent ≈86% of all limb amputations, swing phase. The abnormalities of lateral trunk flexion
and ≈357,000 individuals experienced amputation and forces from vaulting may be contributing factors
at the transfemoral level (2). Ninety-five percent of in the development of back pain, osteoarthritis, or
transfemoral amputations (TFA) are attributable to other chronic overuse conditions (5,6,12,13). As pre-
vascular disease, and the remaining five percent are viously mentioned, LE amputee gait impairments also
due to trauma, malignancy, and congenital limb defi- include significantly increased ambulatory energy
ciencies (2). Further, non-white males, specifically requirements, which may impact overall activity and
African Americans, Hispanics, and Native Americans, participation (8,12,14).
have increased risk of LE amputation (1,3). From Interventions to mitigate gait deviations and
1979 to 1996, there were reportedly 70% more TFA improve quality of life for LE amputees include pre-
patients and 46% more transtibial amputations (TTA) scribing the proper componentry and participating
in males than females (4). Moreover, those older than in physical therapy for gait training. For example,
65 years of age experience 6.5 and 2.7 times the num- to manage TFA patients with gait deviations, an
ber of TFAs and TTAs, respectively, compared to appropriate prosthesis needs to be prescribed. This
those younger than 65 (4). By 2050, the number of includes the choice of socket type (15); knee type,
Americans with amputations is expected to increase such as non-microprocessor or microprocessor knee
from 1.6 million to 3.6 million (1,3). systems (MPK); and foot type to maximally benefit
An individual with LE amputation may face user lifestyle, budget, function, and quality of life. If
increased mortality and morbidity rates, decreased patients frequently ascend and descend stairs in their
quality of life, and impaired function (5). Impaired homes and at work for instance, then perhaps an MPK
function may include gait problems such as move- that facilitates stair ambulation should be considered
ment asymmetry (6). Amputee gait impairments have (16-18). There are numerous factors to consider when
been objectively documented in multiple domains, formulating the prosthetic prescription, including
including spatiotemporal and biomechanical param- patient age, medical history, activity level, goals (e.g.,
eters as well as in terms of bioenergetics (7-9). Gait functional, occupational, recreational, etc.), ampu-
parameters potentially altered in LE amputees include tation length and level, strength, environments (e.g.
changes in magnitude and symmetry of forces and home, work, recreational, etc.), aesthetic preference,
joint moments, event duration, and others (6). These and more. In addition to proper componentry, par-
deviations may contribute to decreased balance and ticipation in physical therapy, including therapeutic
increased metabolic costs as well as more insidious exercise, neuromuscular re-education, and gait train-
chronic issues, potentially including degenerative ing, is beneficial for LE amputees to improve function
joint disease for example (6). TFA patients are and quality of life. Specifically, gait training reportedly
impaired relative to non-amputees due to the lack of improves spatiotemporal parameters, joint kinemat-
muscles controlling their knees. TFA patients depend ics, and bioenergetic efficiency during gait for LE
on a prosthetic knee joint that, despite technological amputees (16,17,19). The purpose of this study was
advancements and functional improvements, limits to systematically review the literature to determine
function to some degree (10). The TFA gait pattern the strength of evidence supporting gait training
is described as having shorter stance and longer interventions and to formulate evidence statements
swing phases on the prosthetic side. Additionally, to guide practice and research related to therapeutic
their gait speed and ability to change speed are also gait training for LE amputees.
REVIEW OF AMPUTEE GAIT TRAINING 101
METHODS following initial criteria within EndNote:
A multidisciplinary review team planned meth- 1. Foreign language (i.e., non-English language)
odology in accordance with that used previously in 2. Non-human subject (i.e., materials science,
prosthetic research (8) in addition to standards estab- finite element studies)
lished by the Prisma Statement (20,21). Reviewers 3. Pediatric studies
had graduate education or professional healthcare
training in physical therapy or prosthetics. The team Following the EndNote search using the afore-
met on three occasions and outlined search method- mentioned exclusion criteria, remaining intervention
ology to include multiple databases and key search articles were divided up equally between reviewers.
terms (primary and secondary) that would assure Each article was assigned a primary and second-
identification of available evidence to address gait ary reviewer. The reviewers independently screened
training interventions for those with LE amputation. references according to inclusion/exclusion criteria
Search methodology was based upon a broad view and classified them as either: 1) pertinent, 2) not
of LE amputations with regard to gait training inter- pertinent or 3) uncertain pertinence. Full-text articles
vention. Preliminary test searches were conducted were reviewed for all citations classified as pertinent
and outcomes previewed at pre-search meetings to or uncertain pertinence. Disagreement regarding
assure adequate inclusion of key articles in terms of citations of uncertain pertinence were resolved by
both quantity and quality within the topic of interest. discussion at weekly follow-up meetings with the
The search statement was planned to be sensitive to two other reviewers. Review of full-text articles and
include patients with LE amputation and gait training associated discussion led to group consensus and ulti-
interventions. The search term sets sought to combine mate inclusion/exclusion. Exclusion criteria applied
all levels of LE amputation with all forms of clinical during the EndNote search were applied at this stage
gait training. Complete search term sets are listed in of screening. Inclusion criteria applied were:
Table 1. 1. Peer-reviewed manuscript
On December 15, 2014, the following databases 2. Gait training intervention for LE Amputees
were searched: 1.) MEDLINE (Pubmed), 2.) the 3. Published within the aforementioned time-
Cumulative Index to Nursing and Allied Health line
Literature (CINAHL)(Ovid), and 3.) Web of Science.
The following date limits were implemented as part Quality Assessment
of the database search parameters: 2000 Jan 1 to 2014
Dec 14. One month after the initial search, the search Evaluation of Internal and External Validity
was repeated by a pair of separate information scien- Methodological quality of included publications
tists. was independently assessed by two reviewers accord-
ing to the American Academy of Orthotists and
Article Screening Prosthetists (AAOP) State-of-the-Science Evidence
Resulting references were exported to EndNote Report Guidelines protocol (22). The AAOP Study
(vX6, Thompson, CA, USA) reference management Design Classification Scale was used to describe the
software. Duplicate references were eliminated. design type of included studies (22). The State of the
Remaining articles were preliminarily sorted by arti- Science Conference (SSC) Quality Assessment Form
cle type. Exclusion criteria were selected to eliminate was used to rate the methodological quality of studies
manuscripts that did not include gait training for classified as experimental (E1 to E5) or observational
adults with LE amputation who used prostheses. (O1 to O6) (22). The form identifies 18 potential
Foreign language articles were eliminated relative threats to internal validity, with the first four threats
to prohibitive costs associated with translation. not applicable for study classifications E3 to E5 and
Manuscripts were screened for exclusion using the the first five threats not applicable for classifications
102 HIGHSMITH ET AL.
Web of Science Gait OR stride OR treadmill* OR walk* OR running OR step OR steps OR stair*OR ramp OR ambulat* OR balance OR climb* OR slope OR "functional training" (Lower AND (extremit* OR limb*)) OR leg OR legs OR hip OR hips OR foot OR feet OR thigh* OR knee OR knees OR ankle* OR femur OR transfemoral OR trans-femoral OR tibia* OR transtibial OR
OR (MH "Functional Training") OR AB thigh*)) AND Implants"))
CINAHL (MH "Walking+") OR gait OR step OR walk OR running OR stair* OR (MH "Stair Climbing") OR ramp OR ambulat* OR balance OR climb* OR slope ((MH "Lower Extremity+") OR (TI lower extrem* OR AB lower extrem*) OR (TI lower limb* OR AB lower limb*) OR (TI leg OR AB leg) OR (TI legs OR AB legs) OR (TI hip OR AB hip) OR (TI hips OR AB hips) OR (TI foot OR AB foot) OR (TI feet
Table 1. Search Term Sets and Databases Table 1. Search Term Sets and Databases MEDLINE Database Gait[mesh] OR gait[tiab] OR gait[ot] OR stride[tiab] OR General stride[ot] OR treadmill* OR walk*[tiab] OR running OR Search step[tiab]OR steps[tiab] OR stair* OR ramp[tiab] OR Term Set ambulat* OR balance[tiab] OR balance[ot] OR climb* OR slope OR "functional training" ((
REVIEW OF AMPUTEE GAIT TRAINING 103
O1 to O6. Threats to validity were evaluated and RESULTS
tabulated. The internal and external validity of each
study was then subjectively rated as “high,” “moder- Literature Search, Sub-topics, and Study Designs
ate,” or “low” based on the quantity and importance The search yielded 11,118 total manuscripts
of threats present. For internal validity, 0 to 3 threats (Figure 1). Following screening, 11,100 manuscripts
was rated “high,” 4 to 6 threats as “moderate,” and were eliminated, leaving 18 articles that met eligibility
7 to 13 or 14 threats as “low.” For external validity, criteria. The 18 remaining articles, published from
the form identifies eight threats. For this study, 0 to 2001 to 2014, were divided into two topical areas:
2 threats to external validity was rated “high,” 3 to 5 1. Overground Training (n = 13) (6,11,16,17,19,25-
threats as “moderate,” and 6 to 8 threats as “low.” Each 32)
study was then given an overall quality of evidence of 2. Treadmill Training (n = 5) (12,33-36)
“high,” “moderate,” or “low” as outlined by the AAOP
State-of-the-Science Evidence Report Guidelines (22). The two most represented journals were Prosthetics
Following the quality assessment of each study, key and Orthotics International (six publications) and
data (e.g., demographic, anthropometric, outcomes, the Journal of Prosthetics and Orthotics (three publi-
etc.) were extracted to assist in describing the stud- cations). All other journals had a single publication,
ied subjects, interventions, and their relative effects. and the group included a dissertation.
Overall ratings from the AAOP State-of-the-Science In terms of study design (22), the case study was
Evidence Report Guidelines were used to assign the most represented (n = 5). There were 11 experimental
level of confidence for the developed empirical evi- studies and two expert opinion manuscripts (Table
dence statements (EES) described in the following 2). None of the included studies had an economic
section. analytic component.
Empirical Evidence Statements Funding
Based on results from the included publications, Eight of the 18 included studies (40%) were
EESs were developed that described study findings unfunded. Local government supported four (20%) of
related to gait training interventions for LE ampu- the studies. Industry and the U.S. National Institutes
tees. Reviewers rated the level of confidence of each of Health each funded 10% of this research. The
EES as “high,” “moderate,” “low,” or “insufficient” remaining studies were sponsored by a university,
based on the number of publications contributing a hospital system, a non-profit organization, or the
to the statement, the methodological quality of those U.S. Department of Defense. Bias risk from a research
studies, and whether the contributing findings were funding perspective was considered low given that
confirmatory or conflicting as similarly outlined by
Table 2. Distribution of Included Studies by Study Design
others (23). These levels of evidence were somewhat Table 2. Distribution of Included Studies by Study Design
adjustable in accordance with study quality, effect
Study Design
size, and other factors. Meta-Analysis (S1) Number of Publications
0
Systematic Review (S2) 0
Analysis Randomized Control Trial (E1) 3
Data pooling (i.e., meta-analyses) was conducted Controlled Trial (E2) 1
Interrupted Time Series Trial (E3)
3
when homogeneous data were available. When data Single Subject Trial (E4) 0
pooling was possible, mean difference with 95% Controlled Before and After Trial (E5) 4
Cohort Study (O1)
0
confidence interval was calculated and significance Case-Control Study (O2) 0
determined a priori to be p ≤ 0.05 (24). Cross Sectional Study (O3) 0
Qualitative Study (O4)
0
Case Series (O5) 0
Sorting by Topic Case Study (O6) 5
Group Consensus (X1) 0
Following procedures for screening and eligibil- Expert Opinion (X2) 2
ity determination, full-text articles were sorted by Total 18
reviewers into sub-topical areas.
104 HIGHSMITH ET AL.
Figure 1. Study flow diagram.
only 10% of the research was funded by industry, with amputation was comparable between traumatic and
the majority being either unfunded or government dysvascular cases and included some malignancy
sponsored. cases. In terms of level of amputation, 57% of the
sample had TFA level amputation, 21% had TTA,
Study Demographics, Interventions, and Outcome
Measures 21% were mixed lower extremity samples, and 1%
were bilaterally involved. Time since amputation was
Conclusions from this systematic review are drawn 5.9 years (9.2, 0.3 to 25.5). The median (mean, IQR,
from 229 subjects (Table 3). Some subjects represent range) sample size was n = 9 (14, 20, 1 to 50).
single projects in multiple manuscripts (11,27,28). Outcome measures assessed included symmetry
A total of 145 persons with lower limb amputation of external work, spatiotemporal measures, biome-
served as experimental subjects. Their mean (inter- chanical and bioenergetic outcomes, level of assist
quartile range (IQR), range) age, height, and mass with functional tasks (i.e., sit to stand, stair climb-
were: 48.2 years (29.5, 31 to 85), 1.7 m (0.04, 1.7 to ing ability), walking test performance, ambulatory
1.8), and 80.6 kg (10.3, 67.4 to 99.3). There were 66 weight bearing, clinical performance measures (i.e.,
amputees who served as control subjects. Their mean timed up and go test), perceptive measures (i.e.,
(IQR, range) age, height, and body mass were: 48.7 Activities-specific Balance Confidence Scale, general
years (27.8, 28 to 66), 1.7 m (0.03, 1.7 to 1.76), and self-efficacy scale), and performance against patient
73.2 kg (5.4, 68 to 82). Eighteen lower limb amputee goals. Due to the varied levels of amputation, methods
subjects served as their own controls in cross-over of data collection, training, and other factors, aggre-
design studies. Finally, an additional 18 non-ampu- gation of data and meta-analysis were not possible.
tees served as controls with a mean age of 35.8 years,
height of 1.7 m, and mass of 72.5 kg. The etiology for
REVIEW OF AMPUTEE GAIT TRAINING 105
Internal and External Validity in two major categories: traditional overground and
Threats to internal validity included lack of inter- treadmill-based training. Beyond this, the evidence
vention blinding, inadequate reporting of eligibility supports general themes with regard to benefits of
criteria, and failure to include statistical analyses (i.e., therapeutic gait training.
expert opinions, editorials) (Table 4). Ten studies had Funding, Subjects, and Outcomes
low, six had moderate, and two had high internal
validity. Conversely, sixteen studies had high and A high number of these studies were unfunded.
two had moderate external validity according to the This is not surprising, as it is less common for com-
mercial parties to have an interest in sponsoring the
AAOP rating tool (Table 5).
development or study of new gait therapies. This
Evidence Statements is likely because gait training therapies commonly
Eight EESs were synthesized from the results represent services rather than products. Therefore,
within the two topical areas previously identified packaging gait training services for a profit is difficult.
(Table 6). One of the statements was supported by The highest amount of funding in this review was
a single study, resulting in an insufficient level of from local government, which may likely be con-
confidence. Four statements had two to four studies nected to academia by way of investigators’ academic
supporting their synthesis, resulting in low confi- affiliations. This is especially surprising given that fed-
dence. One statement was supported by four studies, eral sponsors, such as the U.S. National Institutes of
yielding moderate confidence, and two statements Health, have a mission to apply knowledge to enhance
were supported by sufficient evidence to provide high health, lengthen life, and reduce disability. This body
confidence. Four statements address overground gait of work demonstrates that gait training reduces dis-
training exclusively, one statement addresses tread- ability. Clearly, more federal funding is needed to
mill gait training exclusively, and three statements further enhance this body of gait training research
address both overground and treadmill gait training. in lower limb amputees.
Subjects in the included studies tended to be
DISCUSSION community ambulators of approximately 48 years
The purpose of this study was to systemati- of age who had lost their limbs to either trauma or
cally review the literature to determine the current vascular disease. Additionally, the cohort had a higher
strength of evidence regarding different gait training presence of transfemoral limb loss than other levels.
methods for lower limb amputees and to formulate These characteristics are a bit different than com-
evidence statements to guide current practice and monly cited epidemiologic studies, which describe
future research related to gait training for persons most U.S. amputees as considerably older than 40
with lower limb amputation. This search revealed years and having lost their limbs to vascular disease,
limited literature on the subject, which is consis- most likely at the transtibial level (1,38). These dif-
tent with a recently published systematic review that ferences are not surprising given that transfemoral
identified eight studies investigating the effectiveness amputees may have greater impairment than more
of exercise programs to improve gait performance distal levels of amputation thus justifying heightened
in lower limb amputees (37). The difference in the interest in gait training. Further, given that most sub-
number of studies may be due to the other review jects were community ambulators, it is feasible that
(37) limiting included articles to one-group cohort, the age and etiology would shift lower and toward
pre- to post-test studies, two-group case-control trials, trauma, respectively.
and control trials, whereas this review included all In terms of outcome measures, spatiotemporal,
publications, including expert opinions. Though pub- biomechanical, and bioenergetic measures are com-
lications are limited, our literature review supported mon and logical assessments to determine objectively
our hypothesis that multiple gait training modalities if gait is improving following therapy. Problematically,
are effective to improve overall gait quality in lower these tend to be more research laboratory tools and
limb amputees. Generally, gait training was described less clinically oriented. Therefore, inclusion of obser-
106 HIGHSMITH ET AL.
Conclusions SEW improved in K2 amputees trained to use K3 Gait adaptation occurred w/ functional prosthesis. Unclear benefit at d/c after using either EWA. Partial BWSTT improved speed & gait pattern. Home TM training improved TFA gait. Consider use 12 sessions w/ real-time feedback improved TFA gait. Clinically important changes in biomechanics & VO2. Pts improved WB thru
prosthetic feet. after initial rehab. community integration. loading response. improved in 10 d protocol. safety.
Treatment Duration 1-4 h x 10-14 d accommodation period/ foot Individual need; Rehab duration 78.1 ± 25.3 (40–126 ) d 2x/wk x 8 sessions x 4.5 wks 3x/wk x 8 wks 12 x 30 min sessions x 3 wks 4 x 30 min sessions x 14 d 12 x 30 min sessions; 3x/wk 20-40 min; 3x/wk x 2 wks 1x/wk x 10 mos (range 7-14) 6 x 30 min sessions x 3 wks 12 sessions 10 d NR 10 d
Treatment (Independent Variables) SACH, SAFE, Talux, Proprio; Foot type specific training Pneumatic Post-Amputation Aid; Amputee Mobility Aide 50-60% BWSTT at 1.0-1.6mph 30 min home-based TM training Visual feedback via CAREN VR system & verbal PT feedback In-shoe BW measurement w/ audio feedback; PT feedback for FWB BWSTT (30% BWS), gradually ↓ by 5% intervals; TM
Table 3. Extracted Study Data Table 3. Extracted Study Data N Author (Yr) 10 Agrawal et al. (2013) 15 Barnett et al. (2009) 1 Black et al. (2006)‡ 8 Darter et al. (2013)‡ 1 Darter et al. (2011)‡ 42 Isakov et al. (2006) Lamberg et al. 8 (2014)*‡ 1 Mikami et al. (2014)‡ 9 Sjodahl et al. (2001) 27 Sjodahl et al. (2002) 27 Sjodahl et al. (2003)
106 HIGHSMITH ET AL. REVIEW OF AMPUTEE GAIT TRAINING 107
Table 4. Internal Validity Assessment of Included Manuscriptss
Table 4. Internal Validity Assessment of Included Manuscript
lower extremity amputee. MPH: miles/hour. TM: treadmill. CAREN: computer assisted rehabilitation environment. WB: weight bearing. PT: physical therapy. Amb:
ambulation. LEAFs: lower extremity feedback system. Grp: group. PNF: proprioceptive neuromuscular facilitation. SEW: symmetry of external work. SSWS: self-
*High overall quality score. All other studies were Moderate quality.‡Denotes a treadmill training study. All other studies used overground gait training. BWSTT:
body weight supported treadmill training. BWS: body weight support. BW: body weight. NR: not reported. EWA: early walk aid. FWB: full weight bearing. LEA:
Conclusions SEW improved in K2 amputees trained to use K3 Gait adaptation occurred w/ functional prosthesis. Unclear benefit at d/c after using either EWA. Partial BWSTT improved speed & gait pattern. Home TM training improved TFA gait. Consider use 12 sessions w/ real-time feedback improved TFA gait. Clinically important changes in biomechanics & VO2. Pts improved WB thru PL w/ auditory
proprioceptive neuromuscular facilitation. SEW: symmetry of external work. SSWS: self-selected walking speed. STS: sit to stand. TTA: transtibial amputee.
5
Mod
2002 Sjodahl et al.
E5
prosthetic feet. after initial rehab. community integration. loading response. improved in 10 d protocol. safety. 2001 Sjodahl et al. E5 8 Low
2002 Yigiter et al.
E1
4
Mod
2003 Sjodahl et al.
E5
Mod
4
O6
Low
7
2003 Cole et al.
2005 Faucher et al.
7
O6
Low
2006 Black et al.
1
2006 Isakov et al. O6 9 Low
Low
E1
Mod
5
2009 Barnett et al.
E3
2009 Hyland et al.
High
2
E1
7
2011 Darter et al.
O6
Treatment Duration 1-4 h x 10-14 d accommodation Individual need; Rehab duration 78.1 ± 25.3 (40–126 ) d 2x/wk x 8 sessions x 4.5 wks 12 x 30 min sessions x 3 wks 4 x 30 min sessions x 14 d 12 x 30 min sessions; 3x/wk 20-40 min; 3x/wk x 2 wks 1x/wk x 10 mos (range 7-14) 6 x 30 min sessions x 3 wks 30 min/d x10 sessions *High overall quality score. All other studies were Moder
Low
Low
X2
11
2012 Highsmith et al.
2013 Agrawal et al.
3
Mod
E3
E3
4
2013 Darter et al.
Mod
2
2014 Lamberg et al.
3x/wk x 8 wks
High
E2
12 sessions
period/ foot
Low
O6
2014 Mikami et al.
6
2014 Highsmith et al.
1
X2
Low
10 d
10 d
Boxes that are blacked out are not applicable for the specific study design and thus do not count as threats to validity.
Boxes that are blacked out are not applicable for the specific study design and thus do not count as threats to validity. A dot in the box
NR
NR
A dot in the box indicates the criteria was identified by reviewers whereas a blank box represents a criteria not
indicates the criteria was identified by reviewers whereas a blank box represents a criteria not identified.
identified. that gait training focused on practicing components of
Treatment (Independent Variables) SACH, SAFE, Talux, Proprio; Foot type specific training Pneumatic Post-Amputation Aid; Amputee Mobility Aide 50-60% BWSTT at 1.0-1.6mph 30 min home-based TM training Visual feedback via CAREN VR system & verbal PT feedback In-shoe BW measurement w/ audio feedback; PT feedback for FWB BWSTT (30% BWS), gradually ↓ by 5% intervals; TM w/out support
vational gait scales and perceptive and functional
initiating the task as a whole was an effective strategy
the clinical setting.
to improve overground ambulation and stair negotia-
Overground Gait Training
tion. Superiority of part task versus whole task training
Of the articles included in this review, 13 included
has long been debated (39-41). Here, it seems there is
some form of overground gait training. Multiple
merit in both approaches. For instance, Highsmith et
therapeutic gait interventions, including in-shoe
al. advocated one scenario where breaking down the
auditory feedback (6,26), verbal and tactile cues
subparts of a complex skill (i.e., stair ascent) enabled
training (16,17,25), early weight-bearing (30), early
training as part of a home exercise plan incorporates
Table 3. Extracted Study Data Table 3. Extracted Study Data N Author (Yr) 10 Agrawal et al. (2013) 15 Barnett et al. (2009) 1 Black et al. (2006)‡ 8 Darter et al. (2013)‡ 1 Darter et al. (2011)‡ 42 Isakov et al. (2006) Lamberg et al. 8 (2014)*‡ 1 Mikami et al. (2014)‡ 9 Sjodahl et al. (2001) 27 Sjodahl et al. (2002) 27 Sjodahl et al. (2003) 3 Yang et a
walking aids (32), part or whole task training (31), and
whole task training that has also proved effective (33).
This evidence statement is based on one randomized
combined PT and psychological awareness training
(11,27,28), were identified in our literature review.
control trial (31), one case study (29), and two expert
opinions (16,17).
Sufficient evidence provided moderate confidence
108 HIGHSMITH ET AL.
Table 5. External Validity Assessment of Included Manuscripts
Table 5. External Validity Assessment of Included Manuscripts
Study Classification Sample adequately described Sample representative Outcomes adequately described Outcomes valid for the study Intervention adequately described Findings clinically significant Conclusion placed in literary Findings support conclusions Number of Threats
Year Author context
2001 Sjodahl et al. E5 2
2002 Sjodahl et al. E5 0
2002 Yigiter et al. E1 0
2003 Sjodahl et al. E5 0
2003 Cole et al. O6 3
2005 Faucher et al. O6 2
2006 Black et al. O6 2
2006 Isakov et al. E1 1
2009 Barnett et al. E3 2
2009 Hyland et al. E1 0
2011 Darter et al. O6 2
2012 Yang et al. E5 2
Highsmith et
2012 X2 4*
al.
2013 Agrawal et al. E3 0
2013 Darter et al. E3 0
2014 Lamberg et al. E2 0
2014 Mikami et al. O6 1
Highsmith et
2014 X2 4*
al.
All manuscripts had high external validity except those noted with (*) which had moderate external
All manuscripts had high external validity except those noted with (*) which had moderate external
validity. The three manuscripts by Sjodahl et al. represent a single project and are thus counted as a
validity. The three manuscripts by Sjodahl et al. represent a single project and are thus counted as a
single “manuscript” for the purposes of this review and analysis. A dot in the box indicates the criteria
single “manuscript” for the purposes of this review and analysis. A dot in the box indicates the criteria was
was identified by reviewers whereas a blank box represents a criteria not identified.
identified by reviewers whereas a blank box represents a criteria not identified.
Treadmill-Based Gait Training self-selected walking speed, reliance on an assistive
Improved bioenergetic efficiency was the most device, or gait deviations, as the amputee attempts
prevalent finding for treadmill-based gait training to reduce energy expenditure while ambulating,
that differed from traditional overground gait training therefore emphasizing the importance of improv-
(12,33,36). Lower limb amputees demonstrate a less ing bioenergetic efficiency for this population. Our
efficient gait pattern as observed by higher O2 cost, findings support a low level of evidence that demon-
which becomes more pronounced with higher level strates improved bioenergetic efficiency was observed
of amputation or bilateral involvement (42). This following a supervised treadmill training program
can lead to other gait implications, such as reduced that included a structured home exercise program,
REVIEW OF AMPUTEE GAIT TRAINING 109
Table 6. Evidence Statements, Levels of Evidence, and Overall Confidence
Table 6. Evidence Statements, Levels of Evidence and Overall Confidence
Evidence Statement Level of Evidence Overall
Confidence
†
1. Integration of psychological awareness training Moderate (x2*) 11,28
with a typical gait training program is effective
at improving frontal and sagittal plane joint Low
kinematics in unilateral transfemoral amputees.
†
2. Integration of an in-shoe, auditory feedback Low (x2) 6,26
device into a typical gait training program is
effective at improving involved-side loading in Low
lower limb amputees.
†‡
3. Therapeutic overground or treadmill based gait Low (x5), Moderate (x3),
training under skilled supervision is effective to High (x2) 6,11,12,26,27,31-35
improve spatiotemporal gait parameters in High
transfemoral and transtibial amputees.
4. Following lower extremity amputation, Low (x2), Moderate
‡
bioenergetic efficiency of gait may be improved (x1) 12,33,36
with treadmill based gait training augmented
either by reduced loading, real-time visual Low
feedback, or a structured home-based
program.
†‡
5. Lower limb amputee gait training protocols Low (x4) 29,30,34,36
including typical gait and prosthetic training
procedures with verbal and tactile cues,
ambulation on post-op day 1, and treadmill Low
training with body weight unloading are
effective to increase ambulatory distance with
reduced assistance.
†
6. Gait training utilizing verbal and manual cues Low (x3), High (X1) 16,17,29,31
to practice gait components prior to whole task
initiation is an effective strategy to improve Moderate
overground ambulation and stair negotiation in
lower limb amputees.
7. Combining prosthetic component specific gait Moderate (x1)
†
37
training with appropriate prosthetic foot
prescription can promote higher external work Insufficient
symmetry in limited and unlimited community
ambulating unilateral transtibial amputees.
8. Therapeutic gait training programs under Low (x10), Moderate (x6),
†‡
skilled supervision, that maximize time spent High (x2) 6,11,12,16,17,19,26-37
performing ambulatory activities beyond
current functional daily walking, are safe and High
effective at improving walking function in lower
limb amputees.
†Denotes overground gait training. ‡ Denotes treadmill gait training. *Same study.
† Denotes overground gait training. Denotes treadmill gait training. *Same study.
‡
110 HIGHSMITH ET AL.
anti-gravity training system, or a virtual reality system General Statements
that provides real-time visual feedback. Two out of Due to the high variability of gait training meth-
the three articles to support this statement were case ods identified in the literature, a clear pattern of the
studies (12,36), making current evidence to support most beneficial method of gait training was not able
this statement low. Also, the finding that treadmill to be identified. Conversely, the literature revealed
training is the superior gait training modality to a high level of evidence to support that any of the
improve bioenergetic efficiency is misleading, as none therapeutic gait training programs administered
of the studies that included traditional overground under skilled supervision that increases time spent
gait training methods measured energy consump- performing ambulatory activities beyond the patient’s
tion or expenditure as a primary outcome measure. current functional daily ambulation was effective at
This is most likely explained by the convenience of improving walking function in lower limb amputees
measuring O2 consumption and gas exchange while (6,11,12,16,17,19,25-36). Most studies assessed spa-
participants are relatively fixed on a treadmill versus tiotemporal, joint kinematics, bioenergetic efficiency,
collecting this data while they ambulate over ground. outcome measures, level of assistance, or a combina-
Even so, it is unable to be determined at this time if tion of these to demonstrate improvements in gait.
improved bioenergetics can also be achieved with Subsequently, evidence statements were able to be
overground training methods or if this finding is lim- formed. It is also important to note that adverse or
ited to treadmill training. Therefore, future research safety issues were not reported in connection with
is recommended. the gait training methods studied.
Lamberg et al. compared the effects of body-
weight support treadmill training versus treadmill Spatiotemporal Gait Parameters
training without body-weight support (35). They Current literature supports a high level of evidence
found that treadmill training with and without body- that therapeutic gait training methods, including
weight support is effective to improve six-minute early ambulation with a walking aid (32); in-shoe
walk test distance and timed up and go test time; auditory feedback devices (6,26); psychological
increase treadmill speed; and improve spatiotem- awareness training (11); or treadmill training with or
poral parameters for lower limb amputees with no without body-weight support (34,35), or as a part of a
significant differences found between groups. This structured home exercise plan, are effective to reduce
study reflects similar findings in patients post-stroke spatiotemporal gait deviations. Lower limb amputees
as published in a recent Cochrane review, which demonstrate impaired spatiotemporal gait parame-
concluded that treadmill training with or without ters, including decreased prosthetic limb stance phase
body weight support is effective to improve walking duration, decreased intact limb step length, decreased
speed and endurance (43). These findings have also cadence, and decreased self-selected walking speed
been demonstrated in patients with Parkinson’s dis- compared to a healthy population (7,47). Changes in
ease (44), traumatic brain injury (45), and in some spatiotemporal gait parameters can lead to reduced
patients following orthopedic surgery (46). All of energy efficiency (42) and increased joint stress of
these studies demonstrated carryover to overground intact limb and trunk. Ephraim et al. reported that
training. Beyond providing activity repetitions, the approximately 63% and 49% of amputees experienced
effectiveness of treadmill training may be partially back pain or pain of their intact limb, respectively
attributed to the patients’ ability to practice walking (48). Also, reduced self-selected walking can make
in a safe environment, especially when utilizing a participation in functional and recreational activities
difficult and lead to reduced safety when ambulating
harness system with or without body-weight support in the community, such as being able to cross the
to minimize risk for falls, which improves the patients’ street in an appropriate amount of time (37). This
confidence when attempting to ambulate at increased reinforces the importance of reducing spatiotemporal
speeds.
gait impairments to improve functional mobility,
REVIEW OF AMPUTEE GAIT TRAINING 111
increase safety, and increase amputees’ ability to par- ACKNOWLEDGMENTS
ticipate in their typical functional and recreational Contents of this manuscript represent the opin-
activities. ions of the authors and not necessarily those of the
Joint Kinematics and Loading U.S. Department of Defense, U.S. Department of
Two studies were identified, resulting in low level the Army, U.S. Department of Veterans Affairs, or
confidence to support improved frontal and sagittal any academic or health care institution. Authors
plane joint kinematics when psychological awareness declare no conflicts of interest. This project was
training was integrated into a typical gait training pro- partially funded by the National Institutes of Health
gram (11,28). Two additional studies supported use of Scholars in Patient Oriented Research (SPOR) grant
an auditory feedback device to improve involved side (1K30RR22270).
loading (6,26). In patients with lower limb amputa-
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Technology and Innovation, Vol. 18, pp. 115-123, 2016 ISSN 1949-8241 • E-ISSN 1949-825X
Printed in the USA. All rights reserved. http://dx.doi.org/10.21300/18.2-3.2016.115
Copyright © 2016 National Academy of Inventors. www.technologyandinnovation.org
INTERVENTIONS TO MANAGE RESIDUAL LIMB ULCERATION DUE
TO PROSTHETIC USE IN INDIVIDUALS WITH LOWER EXTREMITY
AMPUTATION: A SYSTEMATIC REVIEW OF THE LITERATURE
1-3
1
4,5
1,7
6
M. Jason Highsmith , Jason T. Kahle , Tyler D. Klenow , Casey R. Andrews , Katherine L. Lewis ,
7
8
Rachel C. Bradley , Jessica M. Ward , John J. Orriola , and James T. Highsmith 10,11
9
1 School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, FL, USA
2 Extremity Trauma & Amputation Center of Excellence (EACE), U.S. Department of Veterans Affairs, Tampa, FL, USA
3 319 Minimal Care Detachment, U.S. Army Reserves, Pinellas Park, FL, USA
th
4 OP Solutions, Tampa, FL, USA
5 Prosthetic Design + Research, Tampa, FL, USA
6 Prosthetics and Sensory Aids Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
Physical Medicine & Rehabilitation Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
7
8 Department of Chemistry, University of South Florida, Tampa, FL, USA
9
Shimberg Health Sciences Library, University of South Florida, Tampa, FL, USA
Dermatology Service, James A. Haley Veterans’ Hospital, Tampa, FL, USA
10
11 Dermatology Surgery Institute, Lutz, FL, USA
Patients with lower extremity amputation (LEA) experience 65% more dermatologic issues
than non-amputees, and skin problems are experienced by ≈75% of LEA patients who use
prostheses. Continuously referring LEA patients to a dermatologist for every stump related skin
condition may be impractical. Thus, physical rehabilitation professionals should be prepared
to recognize and manage common non-emergent skin conditions in this population. The
purpose of this study was to determine the quantity, quality, and strength of available evidence
supporting treatment methods for prosthesis-related residual limb (RL) ulcers. Systematic
literature review with evidence grading and synthesis of empirical evidence statements (EES)
was employed. Three EESs were formulated describing ulcer etiology, conditions in which
prosthetic continuance is practical, circumstances likely requiring prosthetic discontinuance,
and the consideration of additional medical or surgical interventions. Continued prosthetic
use is a viable option to manage minor or early-stage ulcerated residual limbs in compliant
patients lacking multiple comorbidities. Prosthetic discontinuance is also a viable method of
residual limb ulcer healing and may be favored in the presence of severe acute ulcerations,
chronic heavy smoking, intractable pain, rapid volume and weight change, history of chronic
ulceration, systemic infections, or advanced dysvascular etiology. Surgery or other interventions
may also be necessary in such cases to achieve restored prosthetic ambulation. A short bout of
prosthetic discontinuance with a staged re-introduction plan is another viable option that may
be warranted in patients with ulceration due to poor RL volume management. High-quality
prospective research with larger samples is needed to determine the most appropriate course of
treatment when a person with LEA develops an RL ulcer that is associated with prosthetic use.
Key words: Decubitus ulcer; Dermatopathology; Hot spot; Prosthesis; Rehabilitation; Skin
_____________________
Accepted July 1, 2016.
Address correspondence to M. Jason Highsmith, Extremity Trauma & Amputation Center of Excellence (EACE), 8900 Grand Oak Circle (151R), Tampa, FL
33637-1022, USA. Tel: +1 (813) 558-3936; Fax: +1 (813) 558-3990; E-mail: [email protected]
115
116 HIGHSMITH ET AL.
INTRODUCTION physical activity, difficulty performing activities of
Rehabilitation for persons with lower extrem- daily living and occupational tasks, increased fall risk,
ity amputation (LEA) is complex and requires an decreased exercise tolerance, weight gain, financial
interprofessional healthcare team. Members of the hardship, and psychological implications.
multidisciplinary healthcare team for individuals with Alteration to RL shape and volume are common,
LEA may include orthopedic and vascular surgeons, with fluctuation, daily and over the lifespan, contrib-
physiatrists, prosthetists, physical therapists, derma- uting to mismatch between prosthetic socket and RL.
tologists, mental health professionals, and others. Socket to RL volume mismatch is a common prob-
Patients with amputation spend considerable time lem often contributing to skin ulceration. Patients
with physical rehabilitation professionals to learn self- can have a high level of influence on this situation,
care with their new prostheses. During this period, for example, by adding socks. Therefore, monitoring
rehabilitation professionals frequently encounter skin fit and comfort along with other self-management
ulceration of the patient’s residual limb (RL) related techniques are vital to minimize a breakdown of
to prosthetic use. Continuously referring patients skin integrity and function. This project’s aim was to
to a dermatologist for every skin condition may not review the intervention and management of RL ulcers
be practical. Therefore, it is important that physical in persons with LEA who use prostheses. The purpose
rehabilitation professionals are prepared to recognize of this literature review was specifically to determine
and manage common non-emergent skin conditions the quantity, quality, and strength of available evi-
in this population. Proper management should be dence to formulate evidence statements supporting
recommended and may include teaching self-care treatment methods for prosthesis-related RL ulcers.
strategies to the patient as well as recognition of con-
ditions requiring referral. Methods
Currently, more than 80% of amputations in the An interprofessional team was recruited to design
U.S. are the result of complications from vascular dis- the search term set that would best capture man-
ease and diabetes (1,2). Less than 10% of LEA results uscripts to address the project’s aim and purpose.
from trauma (3,4). People with amputation experience The team included the following disciplines: pros-
nearly 65% more dermatologic issues than the general thetics, physical therapy, physiatry, dermatology,
population. Skin problems are experienced by approx- and information science. The PICO (Participants,
imately 75% of patients with LEA who use lower limb Interventions, Comparison, Outcome) framework
prostheses (5). With LEA, the normal pressure-dis- was used to identify key terms relevant to the project’s
tributing anatomy is missing or altered. Therefore, the aim and purpose (7). On the assumption that available
RL is exposed to several atypical conditions with pros- evidence regarding the treatment of pressure ulcers
thetic use. These include elevated shear forces, stress in lower extremity prosthetic users would be lim-
risers, increased humidity, and prolonged moist con- ited, PICO related search terms were selected, tested,
tact within the prosthesis, which can macerate tissue and kept non-specific to identify as many potential
and contribute to ulceration. Ulcers or pressure sores, manuscripts as possible. On November 1, 2014, the
among the more common skin conditions in pros- following search terms, Medical Subject Headings
thetic users, may be mitigated with minor prosthetic (MESH) terms, and Boolean Operators were agreed
adjustments to redistribute pressure (6). However, upon and utilized to search the MEDLINE (Pubmed),
The Cumulative Index to Nursing and Allied Health
the size of areas over which pressures are applied Literature (CINAHL)(Ovid) and Embase databases:
and their magnitude can be considerable and may
require recovery time out of the prosthesis or even ((((((((((((((((((((((lower extremity OR lower
a new socket to be fit (5). Prosthetic disuse can have extremit*)) OR (lower limb OR lower limb*))
many adverse consequences for the patient. These OR leg) OR hip) OR foot) OR knee) OR ankle)
may include weakness, decreased flexibility, reduction OR (above knee OR AK)) OR (below knee OR
of ambulatory ability, functional decline, decreased BK)) OR (transfemoral OR “trans-femoral”))
RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 117
OR (transtibial OR “trans-tibial”)) OR (tran- were not included initially through title and abstract
spelvic OR “trans-pelvic”)) OR (syme’s OR screening. Articles not meeting inclusion criteria
symes))) AND ((((“Amputation”[Mesh]) OR were eliminated. Included articles were then evalu-
amput*) OR disarticulation) OR (hemipelvec- ated using the American Academy of Orthotists and
tomy OR “hemi-pelvectomy”)))) OR stump)) NOT Prosthetists’ (AAOP) evidence rating tool because of
((((((((pirogoff) OR chopart) OR lisfranc) OR its content and population specificity (8). This rating
(transmetatarsal OR “trans-metatarsal”)) OR “ray tool was also selected because it permits evaluation
resection”) OR “ray resections”) OR “ray amputa- of the full range of manuscripts and study designs
tion”) OR “ray amputations”))) AND (ulcer OR (i.e., editorials to meta-analyses). The AAOP rating
ulcerat* OR pressure sore OR pressure ulcer OR tool identifies 18 potential threats to internal valid-
decubit* OR breakdown)) AND (intervention OR ity and eight potential threats to external validity of
treatment OR management OR non-use OR dress- the included experimental, quasi-experimental, and
ing OR negative pressure OR wound vacuum). observational research articles reviewed (Table 1).
Following review and rating, internal and external
Inclusion criteria were based on the definition of validity were then classified as “high,” “moderate,” or
prosthesis-related ulcer and LEA as defined by the “low.” Articles were classified as having high internal
authors. Prosthesis-related ulceration, as defined by or external validity if they met >80% of the tool’s cri-
the authors, referred to an uninfected wound on the teria, moderate internal or external validity if they
RL of a patient with an LEA that occurred from exces- met 60% to 80% of criteria, and low internal or exter-
sive pressure associated with prosthetic use. In this nal validity if they met <60% of the criteria (Table 2).
review, LEA referred to any Syme’s, transtibial, knee
disarticulation, transfemoral, hip disarticulation, or RESULTS
hemipelvectomy amputation of any etiology. Foot
and toe amputations were excluded. To be included, The search identified 3,024 peer-reviewed arti-
manuscripts were required to: cles (Figure 1). Studies involving animal, cadaver,
or modeling; written before January 1, 1990; and/or
1. Include subjects with a lower extremity ampu- not written in English were excluded. Additionally,
tation and a prosthesis-related ulcer on their articles were eliminated based on title when the title
residual limb(s) failed to reasonably support manuscript inclusion.
2. Be published after 1990
3. Study interventions, treatments, or manage- Table 1. Distribution of Included Studies by Study Design
Table 1. Distribution of Included Studies by Study Design
ment of wounds or ulcers in the amputated Number of
residual limb(s) of a person with lower Study Design Publications
extremity amputation who has used or uses Meta-Analysis (S1) 0
Systematic Review
0
a prosthesis Randomized Control Trial (E1) 1
Manuscripts were excluded if they were: Controlled Trial (E2) 0
Interrupted Time Series Trial (E3) 0
1. Studies involving animals, cadavers, or com- Single-Subject Trial (E4) 0
putational modeling (i.e., non-human) Controlled Before and After Trial (E5) 0
2. Published before January 1, 1990 Cohort Study (O1) 1
0
Case-Control Study (O2)
3. Not written in English Cross-Sectional Study (O3) 0
Search results were exported into Endnote reference Qualitative Study (O4) 0
management software (V7, Thompson, CA, USA). Case Series (O5) 1
Case Study (O6)
2
Once imported, reference titles and then abstracts Group Consensus (X1) 0
were screened for inclusion. Full text articles were Expert Opinion (X2) 0
then obtained for review of remaining articles that Total 5
118 HIGHSMITH ET AL. RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 119
Table 2. Internal and External Validity of Included Studies
Table 2. Internal and External Validity of Included Studies These two steps resulted in the elimination of 2,956 of 61.8 years (range: 44 to 80 years) who completed
External articles. A further 46 articles were excluded following their respective studies. Eight subjects did not com-
Study Internal Validity Validity abstract review. Full text articles were obtained and plete their studies, so attrition was 6% when all five
Study
Design 1- 10- 1- reviewed for the remaining 22 references. Of these, studies were considered. The majority of subjects were
4 5 6 7 8 9 11 12 13 14 15 16 17 18 TOTAL 8 TOTAL 17 were excluded based on eligibility criteria. The male (74%) and unilaterally involved at the transtib-
Bruno & remaining five articles (Table 3) were included in the ial level. Only four subjects were bilaterally involved.
Kirby O6 NA NA Mod High evaluation and synthesis. All studies were clinically Most subjects sustained their amputation as a result
(2009)
Karakos O6 NA NA Low High oriented, including one randomized-control trial (9), of peripheral vascular disease. At least three comor-
(2006) one observational cohort study (10), one case series bid diagnoses, but as many as eight comorbidities,
Highsmith (5), and two case studies (11,12). None of the included were reported in some cases. Most ulcers were clas-
& O5 Mod High studies incorporated blinding nor reported effect size. sified as stage II level (13), and the leading diagnostic
Highsmith NA NA
(2007) All studies addressed accommodation and washout methodology was history and physical examination.
Salawu et and were free of conflicts of interest. Also, attrition In some cases, the physical examination was aug-
al. (2006) O1 NA NA High High was addressed in all studies and was <20%; however, mented with either wound measurement or Duplex
Trabellesi attrition rates were not equal among groups due to imaging. Two dependent variables—time to wound
et al. E1 NA High High the inclusion of case studies. Only valid and reliable healing and wound size (or area)—have the prom-
(2012)
outcome measures were used in the included studies. ise of aggregation and synthesis. Unfortunately, due
One study addressed the AAOP instrument’s fatigue
to reporting at an apparently preset follow-up date,
NA is not an available criteria for the indicated study type. Blank spaces indicate the criteria was not identified whereas “•” indicates the and learning criteria. Statistical analysis was appro- rather than at the date of complete healing, wounds
NA is not an available criteria for the indicated study type. Blank spaces indicate the criteria was not
criteria was observed. Mod is moderate.
identified whereas “” indicates the criteria was observed. Mod is moderate. priate, adequately powered, and reported in two of were in various stages of healing upon follow-up.
the five studies. Additionally, exclusion criteria were Therefore, time to healing data could not be aggre-
not discussed in three of the five included studies. gated. Time to healing or time to follow-up were
Finally, since all articles had high external validity, widely varied, with a range from two to 20 weeks.
Figure 1. Study flow diagram and elimination process.
total confidence in the synthesized evidence state- Regarding wound size, the wounds in the Traballesi
ments were predominantly in accordance with the
et al. study (9) were nearly two times the size of those
Articles identified through database searching:
Identification (n=3,024) Articles Eliminated from internal validity ratings. reported in the Salawu et al. study (10). Traballesi
et al. reported mean initial wound areas of 7 cm
In total, conclusions from this report were made
2
from 117 subjects with a mean (interquartile) age
Title Screening
(Vacuum Assisted Suction Suspension (VASS) group)
Table 3. Study Design, Intervention (Use versus Disuse), Demographics, Outcome Measures, Evidence Quality
Articles potentially available (n=2,956) Table 3. Study design, Intervention (Use vs. Disuse), Demographics, Outcome Measures, and Evidence Quality
Overall
for classification of pertinence Study Design* Intervention Sample Age (y) Outcome Measures Quality of
Study
Mean
Screening (n=68) Articles Eliminated from proper use of silicone liners otherwise FIM, Ulcer measurements, Evidence
Size
Use/Disuse
Use, 6 hours per day
Abstract Screening
(n=46) Bruno & Kirby (2009) O6 they will lead to pressure sores. 1 84 Silicone use/disuse for ulcer Moderate
prevention
Ulcer healed 4 months d/c
Articles deemed appropriate Karakos (2006) O6 Disuse. additional interventions: surgery 1 64 Duplex scan Moderate
Eligibility for Full Evaluation Articles Eliminated from 6 months due to pain and ulceration
(Angioplasty)
(n=22)
Case 1: Use, 4 hours per day
Case 2: Disuse, 1 month +
Full Review Highsmith & O5 Case 3: Use, with frequent adjustments 5 45 Returned to independent Moderate
Highsmith (2007)
ambulation and function
Case 4: Disuse 1 week
(n=17) Case 5: Use with wound protection
Articles Included Salawu et al. (2006) O1 Use of prosthetic device with healing 102 60 Changes in surface area of High
Included (n=5) Use of prosthetic device, VAS vs Suction demographics, locomotor
ulcers and photographs,
ulceration
wound cultures
Trabellesi et al.
(2012) E1 socket system following ulcers/wounds 20 61 capability index, visual High
healing. 12 weeks analogue scale
RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 119
These two steps resulted in the elimination of 2,956 of 61.8 years (range: 44 to 80 years) who completed
articles. A further 46 articles were excluded following their respective studies. Eight subjects did not com-
abstract review. Full text articles were obtained and plete their studies, so attrition was 6% when all five
reviewed for the remaining 22 references. Of these, studies were considered. The majority of subjects were
17 were excluded based on eligibility criteria. The male (74%) and unilaterally involved at the transtib-
remaining five articles (Table 3) were included in the ial level. Only four subjects were bilaterally involved.
evaluation and synthesis. All studies were clinically Most subjects sustained their amputation as a result
oriented, including one randomized-control trial (9), of peripheral vascular disease. At least three comor-
one observational cohort study (10), one case series bid diagnoses, but as many as eight comorbidities,
(5), and two case studies (11,12). None of the included were reported in some cases. Most ulcers were clas-
studies incorporated blinding nor reported effect size. sified as stage II level (13), and the leading diagnostic
All studies addressed accommodation and washout methodology was history and physical examination.
and were free of conflicts of interest. Also, attrition In some cases, the physical examination was aug-
was addressed in all studies and was <20%; however, mented with either wound measurement or Duplex
attrition rates were not equal among groups due to imaging. Two dependent variables—time to wound
the inclusion of case studies. Only valid and reliable healing and wound size (or area)—have the prom-
outcome measures were used in the included studies. ise of aggregation and synthesis. Unfortunately, due
One study addressed the AAOP instrument’s fatigue to reporting at an apparently preset follow-up date,
and learning criteria. Statistical analysis was appro- rather than at the date of complete healing, wounds
priate, adequately powered, and reported in two of were in various stages of healing upon follow-up.
the five studies. Additionally, exclusion criteria were Therefore, time to healing data could not be aggre-
not discussed in three of the five included studies. gated. Time to healing or time to follow-up were
Finally, since all articles had high external validity, widely varied, with a range from two to 20 weeks.
total confidence in the synthesized evidence state- Regarding wound size, the wounds in the Traballesi
ments were predominantly in accordance with the et al. study (9) were nearly two times the size of those
internal validity ratings. reported in the Salawu et al. study (10). Traballesi
In total, conclusions from this report were made et al. reported mean initial wound areas of 7 cm
2
from 117 subjects with a mean (interquartile) age (Vacuum Assisted Suction Suspension (VASS) group)
Table 3. Study design, Intervention (Use vs. Disuse), Demographics, Outcome Measures, and Evidence Quality
Table 3. Study Design, Intervention (Use versus Disuse), Demographics, Outcome Measures, Evidence Quality
Overall
Study Intervention Sample Mean
Study Outcome Measures Quality of
Design* Use/Disuse Size Age (y)
Evidence
Use, 6 hours per day
proper use of silicone liners otherwise FIM, Ulcer measurements,
Bruno & Kirby (2009) O6 they will lead to pressure sores. 1 84 Silicone use/disuse for ulcer Moderate
Ulcer healed 4 months d/c prevention
Disuse. additional interventions: surgery
Karakos (2006) O6 (Angioplasty) 1 64 Duplex scan Moderate
6 months due to pain and ulceration
Case 1: Use, 4 hours per day
Case 2: Disuse, 1 month +
Highsmith & O5 Case 3: Use, with frequent adjustments 5 45 Returned to independent Moderate
Highsmith (2007) ambulation and function
Case 4: Disuse 1 week
Case 5: Use with wound protection
Changes in surface area of
Use of prosthetic device with healing
Salawu et al. (2006) O1 102 60 ulcers and photographs, High
ulceration
wound cultures
Use of prosthetic device, VAS vs Suction demographics, locomotor
Trabellesi et al. E1 socket system following ulcers/wounds 20 61 capability index, visual High
(2012)
healing. 12 weeks analogue scale
120 HIGHSMITH ET AL. RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 121
and 6.3 cm (control/suction socket group) compared DISCUSSION for prosthetists to educate patients regarding the risk unilateral transtibial patients (five male, one female,
2
with mean initial wound areas of 3.6 cm in estab- The purpose of this review was to determine of developing an ulcer as well as numerous methods mean age = 66.5 years, mean weight = 94.6 kg) of
2
lished prosthesis users and 3.1 cm in new prosthesis the quantity, quality, and consistency of available of preventing and managing them should they arise, vascular (n = 5) and traumatic (n = 1) etiology pre-
2
users reported by Salawu et al. (9,10). Further, these evidence to formulate evidence statements support- including proper device utilization and volume man- scribed VASS prostheses upon presentation with an
wound area measures were made using vastly different ing treatment methods for prosthesis-related RL agement. Specifically, skin ulcers reportedly develop open RL wound (20). Subjects had several comor-
methodologies. For instance, there were manual mea- ulcers. The review identified five articles (Table 3) in nearly 27% of diagnosed skin problems in pros- bidities, including Diabetes Mellitus Type 1 and 2,
surements (10) and scaled on-screen measurements that described the treatment of RL ulceration in 117 thetic users (14). The responsibility for preventing peripheral vascular disease, Charcot joint disease,
taken in software (9). These differences in wound area amputee subjects. With the exception of four bilat- and managing ulcers in the residual limbs of pros- retinopathy, hearing impairment, dermatillomania,
measurement methodologies further complicate the erally involved individuals, subjects had a history thetic users is shared between the prosthetist, who and history of chronic alcohol and tobacco use. All
ability to aggregate data for meta-analyses. of unilateral transtibial amputation of vascular or provides a properly fit device and educates the patient, subjects received physiatrist-prescribed wound care
Ultimately, prosthetic continuance or prosthetic unknown etiologies. The subjects were mostly elderly and the patient, who should practice diligent self-care and were instructed to continue prosthetic use “as
discontinuance were the predominant interven- and had multiple comorbidities, including Type 2 and compliance. much as possible given any pain they may experi-
tion options available to manage RL ulcers related Diabetes Mellitus, coronary artery disease, hyperten- Controversy exists as to whether continued ence and not to limit their activities” (20). Vacuum
to prosthetic use. Multiple adjuvant interventions sion, hyperlipidemia, chronic venous insufficiency, prosthetic use is indicated for amputees with RL pump and prosthetic foot type were not controlled.
were included within the themes of prosthetic con- neuropathy, anemia, post-herpetic neuralgia, pru- ulcerations because ambulation has many physio- Wound size (determined by software analysis of ulcer
tinuance (i.e., use) or discontinuance (i.e., disuse). ritus, and chronic smoking. All subjects received logical benefits that improve wound healing (15), photographs) and time to complete wound closure
These adjunct interventions included: such as increased circulation (16), tissue oxygenation were primary outcome measures. Wound surface
modification of prosthetic use, including restriction (16,17), and fluid filtration (17). Prolonged inactiv- area was 2.17 ± 0.65 cm (initially) and mean time
2
1. Prosthetic modification or adjustment and disuse, as an intervention. ity, which is often associated with prosthetic disuse, is to wound closure was 117 ± 113 d (range: 40 to 380
2. Planned progressive prosthetic re-introduction The first empirical evidence statement (EES) associated with several deleterious effects on health, d). During that period, one subject was non-com-
3. Patient education addressed development of an ulcer relative to including reduced functional capacity, respiratory pliant with proper use protocols for a short time
4. Continued prosthetic use (VASS, suction, or improper volume management and utilization of function, skin integrity, and oxygen transportation (≈20 d), another had a hole in the sealing sleeve that
usual suspension) with wound care (during interface components (Table 4). Scenarios that can (17) as well as muscle atrophy (18). This list is not required repair (at ≈100 d), and a third subject suf-
disuse periods or scheduled) contribute to ulceration include weight gain or loss, inclusive of negative psychological effects of inactiv- fered a fall requiring surgery and rehabilitation (at
changes in activity, medication and physiologic ity, such as depression, anxiety, and psychosomatic
Finally, three evidence statements were synthesized changes, componentry damage, patient compliance ≈30 d). Authors concluded VASS prostheses may be
from the results. The topics addressed were 1) ulcer fatigue (19). used while managing RL wounds in transtibial ampu-
etiology, 2) continued prosthetic use, and 3) cessa- issues, and improper patient education. Confidence In the event that an ulcer develops, there are tation patients. Results further suggest a well-fitting
in this statement was moderate. It is standard practice
tion of prosthetic use (Table 4). numerous management options, including pros- VASS socket does not preclude RL wound healing
thetic use or disuse. EES 2 (Table 4) indicates that, and closure in compliant users even without activity
in the absence of comorbidities that may delay healing limitation (20). This recently published data sup-
and impair cognition, patient education and modi- ports EES 2 and suggests that continued prosthetic
Table 4. Empirical Evidence Statements fied prosthetic use with or without elevated vacuum use without activity restrictions may be possible in
Table 4. Empirical Evidence Statements
suspension is safe, can reduce ulcer size, and result the presence of common diabetic-related complica-
Level of
Empirical Evidence Statement Supporting Studies Category in limited but continued function during healing. tions when VASS is utilized. It further suggests that,
Confidence
Improper volume management and utilization of Bruno & Kirby (2009) [Moderate] Conversely, EES 3 (Table 4) indicates that prosthetic on a per-case basis, comorbidities do not preclude
interface components can result in ulceration to the Highsmith & Highsmith (2007) Moderate Ulcer etiology disuse with or without alternative interventions such
skin of the residual limb. [Moderate] continued prosthetic use in the presence of a resid-
as surgery or systemic antibiotics may be indicated ual limb ulcer.
Following development of an ulcer, in the absence of Bruno & Kirby (2009) [Moderate] in the case of residual limbs that ulcerate in the pres-
comorbidities that delay healing and impair Highsmith & Highsmith (2007)
cognition, patient education and modified prosthetic [Moderate] ence of chronic heavy smoking, intractable pain, rapid Limitations
use with or without elevated vacuum suspension is Salawu et al. (2006) [High] Moderate Continued prosthetic use volume and weight change, history of chronic ulcer- Though most included articles demonstrated
safe, can reduce ulcer size, and result in limited but Trabellesi et al. (2012) [High]
continued function during healing. ation, systemic infections, or advanced dysvascular moderate to high internal validity and high exter-
Prosthetic disuse and/or alternative interventions Karakos (2006) [Moderate] etiology. The confidence in both statements is mod- nal validity, only one randomized control trial was
such as surgery or systemic antibiotics, may be Highsmith & Highsmith (2007) erate based on available evidence. included. This indicates substantial need for more
indicated in the case of residual limbs that ulcerate in [Moderate]
the presence of chronic heavy smoking, intractable Moderate Cessation of prosthetic use An additional case series, published after conduct- high-quality research including more randomized
pain, rapid volume and weight change, history of ing this review, reported on continued prosthetic use control trials to determine the optimal treatment
chronic ulceration, systemic infections, or
dysvascular etiology. in ulcerative care. Hoskins et al. described six (n = 6) methods to reduce wound healing time and increase
RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 121
for prosthetists to educate patients regarding the risk unilateral transtibial patients (five male, one female,
of developing an ulcer as well as numerous methods mean age = 66.5 years, mean weight = 94.6 kg) of
of preventing and managing them should they arise, vascular (n = 5) and traumatic (n = 1) etiology pre-
including proper device utilization and volume man- scribed VASS prostheses upon presentation with an
agement. Specifically, skin ulcers reportedly develop open RL wound (20). Subjects had several comor-
in nearly 27% of diagnosed skin problems in pros- bidities, including Diabetes Mellitus Type 1 and 2,
thetic users (14). The responsibility for preventing peripheral vascular disease, Charcot joint disease,
and managing ulcers in the residual limbs of pros- retinopathy, hearing impairment, dermatillomania,
thetic users is shared between the prosthetist, who and history of chronic alcohol and tobacco use. All
provides a properly fit device and educates the patient, subjects received physiatrist-prescribed wound care
and the patient, who should practice diligent self-care and were instructed to continue prosthetic use “as
and compliance. much as possible given any pain they may experi-
Controversy exists as to whether continued ence and not to limit their activities” (20). Vacuum
prosthetic use is indicated for amputees with RL pump and prosthetic foot type were not controlled.
ulcerations because ambulation has many physio- Wound size (determined by software analysis of ulcer
logical benefits that improve wound healing (15), photographs) and time to complete wound closure
such as increased circulation (16), tissue oxygenation were primary outcome measures. Wound surface
(16,17), and fluid filtration (17). Prolonged inactiv- area was 2.17 ± 0.65 cm (initially) and mean time
2
ity, which is often associated with prosthetic disuse, is to wound closure was 117 ± 113 d (range: 40 to 380
associated with several deleterious effects on health, d). During that period, one subject was non-com-
including reduced functional capacity, respiratory pliant with proper use protocols for a short time
function, skin integrity, and oxygen transportation (≈20 d), another had a hole in the sealing sleeve that
(17) as well as muscle atrophy (18). This list is not required repair (at ≈100 d), and a third subject suf-
inclusive of negative psychological effects of inactiv- fered a fall requiring surgery and rehabilitation (at
ity, such as depression, anxiety, and psychosomatic ≈30 d). Authors concluded VASS prostheses may be
fatigue (19). used while managing RL wounds in transtibial ampu-
In the event that an ulcer develops, there are tation patients. Results further suggest a well-fitting
numerous management options, including pros- VASS socket does not preclude RL wound healing
thetic use or disuse. EES 2 (Table 4) indicates that, and closure in compliant users even without activity
in the absence of comorbidities that may delay healing limitation (20). This recently published data sup-
and impair cognition, patient education and modi- ports EES 2 and suggests that continued prosthetic
fied prosthetic use with or without elevated vacuum use without activity restrictions may be possible in
suspension is safe, can reduce ulcer size, and result the presence of common diabetic-related complica-
in limited but continued function during healing. tions when VASS is utilized. It further suggests that,
Conversely, EES 3 (Table 4) indicates that prosthetic on a per-case basis, comorbidities do not preclude
disuse with or without alternative interventions such continued prosthetic use in the presence of a resid-
as surgery or systemic antibiotics may be indicated ual limb ulcer.
in the case of residual limbs that ulcerate in the pres-
ence of chronic heavy smoking, intractable pain, rapid Limitations
volume and weight change, history of chronic ulcer- Though most included articles demonstrated
ation, systemic infections, or advanced dysvascular moderate to high internal validity and high exter-
etiology. The confidence in both statements is mod- nal validity, only one randomized control trial was
erate based on available evidence. included. This indicates substantial need for more
An additional case series, published after conduct- high-quality research including more randomized
ing this review, reported on continued prosthetic use control trials to determine the optimal treatment
in ulcerative care. Hoskins et al. described six (n = 6) methods to reduce wound healing time and increase
122 HIGHSMITH ET AL. RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 123
overall function for patients with a prosthesis-re- declare no conflicts of interest. This project was par- Med. 2012;48:613-23. 16. Genc A, Ozyurek S, Koca U, Gunerli A. Respira-
lated RL ulcer. Meta-analyses were not possible due tially funded by the National Institutes of Health 10. Salawu A, Middleton C, Gilbertson A, Kodavali tory and hemodynamic responses to mobilization
to a lack of standardized wound assessment scales Scholars in Patient Oriented Research (SPOR) grant K, Neumann V. Stump ulcers and contin- of critically ill obese patients. Cardiopulm Phys
and measures. Additionally, subjects in the included (1K30RR22270). ued prosthetic limb use. Prosthet Orthot Int. Ther J. 2012;23:14-8.
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will generalize to younger subjects with ulcers in dif- 1. Turney BW, Kent SJ, Walker RT, Loftus IM. prosthesis silicone liner causing pressure ulcer- effect of supine lying position along with mobili-
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Coll Surg Edinb. 2001;46:271-3. 12. Karkos CD, Bright E, Bolia A, London NJ. Sub- zation over half lying position head up 45 degree
CONCLUSION 2. Taylor SM, Kalbaugh CA, Blackhurst DW, intimal recanalization of the femoropopliteal in patients following open heart surgery. Int J
This systematic review indicates that continued Hamontree SE, Cull DL, Messich HS, Robert- segment to promote healing of an ulcerated Thoracic Cardiovasc Surg. 2009;13:9.
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prosthetic use is a viable option to manage a residual son RT, Langan EM 3 , York JW, Carsetn CG 3rd, below-knee amputation stump. J Endovasc Ther. 18. Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss
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pliant patient lacking comorbidities that would likely clinical factors predict postoperative functional 13. Sussman CB, Bates-Jensen BM. Wound care: a ture: effects on function and mortality. Arch
delay healing. Conversely, prosthetic discontinuance outcomes after major lower limb amputation: an collaborative practice manual for health profes- Intern Med. 2006;166:766-71.
is also a viable method of residual limb ulcer healing analysis of 553 consecutive patients. J Vasc Surg. sionals. 4 ed. Philadelphia (PA): Wolters Kluwer 19. Berlin AA, Kop WJ, Deuster PA. Depressive
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in the presence of multiple comorbidities that delay 2005;42:227-35. Health/Lippincott Williams & Wilkins; 2012. mood symptoms and fatigue after exercise with-
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pain, rapid volume and weight change, history of of amputations and limb deficiencies: surgical, JP. Dermatologic conditions associated with use Psychosom Med. 2006;68:224-30.
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or advanced dysvascular etiology. Surgery, physi- Rosemont (IL): American Academy of Ortho- Rehabil. 2005;86:659-63. Fatone S. Using vacuum-assisted suspension to
cal rehabilitation, or other interventions may also paedic Surgeons; 2004. 15. Eisenbud DE. Oxygen in wound healing: nutrient, manage residual limb wounds in persons with
be necessary in such cases to achieve restored pros- 4. Zeigler-Graham K, Mackenzie EJ, Ephraim PL, antibiotic, signaling molecule, and therapeutic transtibial amputation: a case series. Prosthet
thetic ambulation. Evidence suggests that continued Travison TG, Brookmeyer R. Estimating the agent. Clin Plast Surg. 2012;39:293-310. Orthot Int. 2014;38:68-74.
use of specific sockets (i.e., VASS) in select compli- prevalence of limb loss in the United States: 2005
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wound healing (i.e., diabetes), may not be detrimen- 5. Highsmith JT, Highsmith MJ. Common skin
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with ulceration due to poor residual limb volume stra PU. Skin problems of the stump in lower
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studied returned to prosthetic use and ambulation Venereol. 2011;91:173-7.
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Guidelines. Washington (DC): American Acad-
ACKNOWLEDGMENTS emy of Orthotists & Prosthetists; 2008.
Contents of this manuscript represent the opin- 9. Traballesi M, Delussu AS, Fusco A, Iosa M,
ions of the authors and not necessarily those of the Averna T, Pellegrini R, Brunelli S. Residual limb
U.S. Department of Defense, U.S. Department of wounds or ulcers heal in transtibial amputees
the Army, U.S. Department of Veterans Affairs, or using an active suction socket system. A ran-
any academic or health care institution. Authors domized controlled study. Eur J Phys Rehabil
RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 123
Med. 2012;48:613-23. 16. Genc A, Ozyurek S, Koca U, Gunerli A. Respira-
10. Salawu A, Middleton C, Gilbertson A, Kodavali tory and hemodynamic responses to mobilization
K, Neumann V. Stump ulcers and contin- of critically ill obese patients. Cardiopulm Phys
ued prosthetic limb use. Prosthet Orthot Int. Ther J. 2012;23:14-8.
2006;30:279-85. 17. Wani I, Sangeen S, Khan Q, Wani M, Shah Z,
11. Bruno TR, Kirby RL. Improper use of a transtibial Baneerje A, Balsaree D. Study to compare the
prosthesis silicone liner causing pressure ulcer- effect of supine lying position along with mobili-
ation. Am J Phys Med Rehabil. 2009;88:264-6. zation over half lying position head up 45 degree
12. Karkos CD, Bright E, Bolia A, London NJ. Sub- in patients following open heart surgery. Int J
intimal recanalization of the femoropopliteal Thoracic Cardiovasc Surg. 2009;13:9.
segment to promote healing of an ulcerated 18. Siu AL, Penrod JD, Boockvar KS, Koval K, Strauss
below-knee amputation stump. J Endovasc Ther. E, Morrison RS. Early ambulation after hip frac-
2006;13:420-3.
13. Sussman CB, Bates-Jensen BM. Wound care: a ture: effects on function and mortality. Arch
collaborative practice manual for health profes- Intern Med. 2006;166:766-71.
sionals. 4 ed. Philadelphia (PA): Wolters Kluwer 19. Berlin AA, Kop WJ, Deuster PA. Depressive
th
Health/Lippincott Williams & Wilkins; 2012. mood symptoms and fatigue after exercise with-
14. Dudek NL, Marks MB, Marshall SC, Chardon drawal: the potential role of decreased fitness.
JP. Dermatologic conditions associated with use Psychosom Med. 2006;68:224-30.
of a lower-extremity prosthesis. Arch Phys Med 20. Hoskins RD, Sutton EE, Kinor D, Schaeffer JM,
Rehabil. 2005;86:659-63. Fatone S. Using vacuum-assisted suspension to
15. Eisenbud DE. Oxygen in wound healing: nutrient, manage residual limb wounds in persons with
antibiotic, signaling molecule, and therapeutic transtibial amputation: a case series. Prosthet
agent. Clin Plast Surg. 2012;39:293-310. Orthot Int. 2014;38:68-74.
Technology and Innovation, Vol. 18, pp. 125-137, 2016 ISSN 1949-8241 • E-ISSN 1949-825X
Printed in the USA. All rights reserved. http://dx.doi.org/10.21300/18.2-3.2016.125
Copyright © 2016 National Academy of Inventors. www.technologyandinnovation.org
PREDICTING WALKING ABILITY FOLLOWING LOWER LIMB
AMPUTATION: AN UPDATED SYSTEMATIC LITERATURE REVIEW
1,2
Jason T. Kahle , M. Jason Highsmith , Hans Schaepper , Anton Johannesson ,
6
7
3-5
Michael S. Orendurff , and Kenton Kaufman 9
8
1 OP Solutions, Tampa, FL, USA
2 Prosthetic Design + Research, Tampa, FL, USA
3 School of Physical Therapy & Rehabilitation Sciences, University of South Florida, Tampa, FL, USA
4 Extremity Trauma & Amputation Center of Excellence (EACE), U.S. Department of Veterans Affairs, Tampa, FL, USA
th
5 319 Minimal Care Detachment, U.S. Army Reserves, Pinellas Park, FL, USA
6 Orthotics and Prosthetics Department, Loma Linda University, Loma Linda, CA, USA
7 Össur Nordic, Stockholm, Sweden
8 Motion & Sports Performance Laboratory, Lucile Packard Children’s Hospital Stanford, Palo Alto, CA, USA
9 Motion Analysis Laboratory, Mayo Clinic, Rochester, MN, USA
There is not a clear clinical recommendation for the determination of prosthetic candidacy.
Guidelines do not delineate which member(s) of the multidisciplinary team are responsible
for prosthetic candidacy decisions and which factors will best predict a positive outcome.
Also not clearly addressed is a patient-centered decision-making role. In a previous systematic
review (SR), Sansam et al. reported on the prediction of walking ability following lower limb
amputation using literature up to 2007. The search strategy was designed from the previous
Sansam SR as an update of previously valuable predictive factors of prosthetic candidacy. An
electronic literature search was executed from August 8, 2007, to December 31, 2015, using
MEDLINE (Pubmed), Embase, The Cumulative Index to Nursing and Allied Health Literature
(CINAHL) (Ovid), and Cochrane. A total of 319 studies were identified through the electronic
search. Of these, 298 were eliminated, leaving a total of 21 for full evaluation. Conclusions from
this updated study are drawn from a total recruited sample (n) of 15,207 subjects. A total of
12,410 subjects completed the respective studies (18% attrition). This updated study increases
the size of the original Sansam et al. report by including 137% more subjects for a total of 21,490
between the two articles Etiology, physical fitness, pre-amputation living status, amputation
level, age, physical fitness, and comorbidities are included as moderate to strongly supported
predictive factors of prosthetic candidacy. These factors are supported in an earlier literature
review and should be strongly considered in a complete history and physical examination by
a multidisciplinary team. Predictive factors should be part of the patient’s healthcare record.
Key words: Amputee; Physical therapy; Prosthesis; Rehabilitation; Functional level; Prosthetic
candidacy
_____________________
Accepted July 1, 2016.
Address correspondence to Jason T. Kahle, OP Solutions, 12206 Bruce B. Downs Blvd., Tampa, FL 33612, USA. Tel: +1 (813) 971-1100; Fax: +1 (813) 971-
9300; E-mail: [email protected]
125
126 KAHLE ET AL.
INTRODUCTION and update using similar methods from a previous
Guidelines for amputee rehabilitation are available SR to help establish a wider, more current base of
nationally and internationally (1-4). However, there evidence regarding walking ability following lower
is not a clear clinical recommendation for the deter- limb amputation.
mination of prosthetic candidacy. Moreover, while
multidisciplinary decision support is recognized in METHODS
the aforementioned guidelines, the guidelines do not Search Strategy for Extension of Previous Sansam
delineate which member(s) of the multidisciplinary et al. Systematic Review
team are responsible for prosthetic candidacy deci-
sions nor which factors will best predict a positive An electronic literature search was executed from
outcome. Also not clearly addressed is a patient-cen- August 1, 2007, to December 31, 2015, using MED-
tered decision-making role, which is crucial to any LINE (Pubmed), Embase, The Cumulative Index to
clinical decision process. Nursing and Allied Health Literature (CINAHL)
In a systematic review (SR), Sansam et al. reported (Ovid), and Cochrane and using the following key-
on the prediction of walking ability following lower words in the title or abstract:
extremity amputation (LEA) (5). Conclusions of that Amput* AND ambulat* OR mobil* OR walk* AND
SR were that adequately powered prospective studies predict* OR prognos* OR probability
reporting predictive ability of factors measured before
the onset of rehabilitation could accurately estimate Manuscripts were selected or eliminated based on
an individual’s walking potential (5). Prospective the following criteria:
reports could establish clinic practice guidelines Inclusion criteria:
(CPG) for predicting prosthetic candidacy and • Adult subjects with unilateral or bilateral lower
functional level. Further, predictive factors that are limb amputation
modifiable through preemptive therapies could be • Published after August 1, 2007
explored further to establish whether targeting these • Examined the relationship between predictive
factors would lead to improvements in walking out- variables recorded prior to amputee rehabilita-
come. Lastly, Sansam et al. reported there was mixed tion and measures of walking ability following
heterogeneity of methods and outcome measures used rehabilitation
in comparing predictive factors (5). Investigation • Studies using health outcomes with a mobility
of predictive factors is needed to estimate walking component, such as the Functional Indepen-
potential more accurately, targeting modifiable factors dence Measure
to optimize outcome after LEA. Ultimately, this would • English language
help establish much needed CPGs (5). All factors • Observational, retrospective studies if predic-
should be considered when determining walking tor variables were available
capacity, as not walking following amputation could • Randomized clinical trials
lead to physical deterioration and comorbidities and Exclusion criteria:
be detrimental to overall health (6,7). • Non-adult
The quality of rehabilitation studies has improved • Prosthetic device or rehabilitation interven-
in the last decade (8). Sansam et al.’s SR included tions studies
literature up to August 2007. There have been many • Animal studies
changes and proposed changes to health care regard- • Case reports and series
ing LEA, particularly in the U.S. These changes may • Letters, editorials, conference proceedings
have initiated more contemporary reports of predict- • Manuscripts from developing nations
ing walking ability. Therefore, the purpose of this SR
is to establish factors to predict walking ability with a Two authors independently assessed selected
prosthesis following LEA. This review is an extension papers for content, quality, and critical appraisal.