Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Amputation
Type
Observational
Design
Observational Model: CohortTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Description

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 u...

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.

Tracking Information

NCT #
NCT03828331
Collaborators
Not Provided
Investigators
Principal Investigator: Alena Grabowski, PhD BA Rocky Mountain Regional VA Medical Center, Aurora, CO