Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:4/6/2019
Start Date:April 1, 2019
End Date:March 31, 2021
Contact:Alena Grabowski, PhD BA
Email:Alena.Grabowski@va.gov
Phone:(720) 435-4270

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Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2
diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize
bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or
the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and
reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and
improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective
prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment
times and fewer revisits for Veterans with TTAs. The investigators will determine the
physiological and biomechanical effects of different prosthetic and bicycle configurations
for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The
investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm
length for the affected compared to the unaffected leg along with a pedal attachment position
beneath the pylon compared to beneath the forefoot will optimize performance for Veterans
with TTAs the investigators' research will integrate evidence-based guidelines to advance
rehabilitation and enhance the lives of Veterans with an amputation, thus improving and
restoring their function.

Over one million people in the United States have a leg amputation and this number continues
to grow due to the prevalence of diabetes and recent military conflicts. Because of the
functional impairment caused by an amputation, it is extremely important to advance
rehabilitation that optimizes the use of prostheses so that Veterans with amputations can
regain the greatest possible level of health, function, and physical activity. Low-impact
exercise such as bicycling could facilitate return to work/duty after amputation by improving
cardiovascular fitness, muscle strength, endurance, and quality of life for Veterans with
transtibial amputations (TTAs). Bicycling as exercise could also prevent the deleterious
effects of vascular disease and diabetes by improving cardiovascular function, controlling
body weight, decreasing the rate of re-amputation, and improving quality of life for Veterans
with TTAs. However, it is likely that discomfort and the increased potential for secondary
musculoskeletal injury due to the lack of a proper prosthetic/bike fit discourages Veterans
with TTAs from using bicycling for rehabilitation and exercise. Moreover, it is unclear how
prosthetic and bicycle components, such as pylon length (PL), pedal attachment position (PAP)
beneath the prosthetic forefoot versus the pylon, and crank arm length (CAL) affect the
biomechanics, metabolic costs, and comfort/ satisfaction of Veterans with TTAs. Thus, the
investigators' goal is to challenge the state-of-the-science by developing evidence-based
prosthetic and bicycle fit guidelines that optimize the biomechanics, metabolic costs,
efficiency (mechanical power/metabolic power) and comfort/satisfaction for Veterans with
TTAs. The Department of Veterans Affairs (VA) and Department of Defense (DoD) Rehabilitation
Directive has put forth an initiative that aims to dramatically improve and restore function
in wounded Veterans and Service members so that they have the choice to return to active duty
or productive civilian employment. The proposed research will establish optimal
prosthetic/bicycle fit guidelines, which would enhance function by improving cardiovascular
health, controlling body weight, decreasing re-amputation rates, and enhancing quality of
life of Veterans with TTAs, thus helping to fulfill this initiative and having high potential
impact. Specifically, the investigators aim to: 1) Study 15 Veterans with unilateral TTAs to
determine the effects of systematically varying PL, PAP beneath the prosthetic forefoot
versus the pylon, and CAL for the affected leg on bicycling biomechanics, metabolic costs,
and comfort/satisfaction. 2) Synthesize and disseminate the investigators' findings into
practical, evidence-based quantitative prosthetic/bicycle fit guidelines for Veterans with
TTAs. The investigators hypothesize that a longer PL and shorter CAL for the affected
compared to the unaffected leg along with a PAP beneath the pylon compared to beneath the
forefoot will maximize mechanical power symmetry and reduce metabolic cost and muscle
activity, and thus maximize efficiency and comfort/satisfaction during bicycling in Veterans
with unilateral TTAs. The utilization of evidence-based prosthetic/bicycle fit guidelines
that increase symmetry, improve comfort, reduce the risk of injury, decrease metabolic costs,
and improve efficiency will directly benefit Veterans with TTAs by increasing their physical
activity and function. Optimized prosthetic/bicycle fit guidelines will allow Veterans TTAs
who were previously unable to comfortably ride a bicycle, as well as those currently riding a
bicycle, to ride longer with less effort and discomfort, potentially leading to an improved
quality of life. Moreover, the prosthetic/bicycle fit guidelines generated by this research
will ensure that clinicians are able to fit Veterans with TTAs to bicycles more effectively,
leading to shorter appointment times and fewer revisits due to enhanced function and reduced
comorbidities.

Inclusion Criteria:

- One amputation below the knee

- At least 1 year of experience using a prosthesis

- No current problems with the prosthesis or residual limb

- At or above a K3 Medicare Functional Classification Level

Exclusion Criteria:

- Poor general health

- Difficulty with mobility

- Problems with balance or dizziness

- Current serious musculoskeletal injury besides that associated with an amputation

- Cardiovascular, pulmonary, or neurological disease or disorder
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Alena Grabowski, PhD BA
Phone: 720-435-4270
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Aurora, CO
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