N/A
Completed N=12
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
Amputation
Source: ClinicalTrials.gov NCT03828331 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Mechanical Crank Power Output — 0.59; 0.99; 0.60; 0.97 W/kg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mechanical Crank Power Output |
0.59; 0.99; 0.60; 0.97; 0.59; 0.95 | — |
| PRIMARY Net Metabolic Power |
7.06; 7.18; 7.09; 6.94; 7.13; 7.14 | — |
| PRIMARY Perceived Comfort (Visual Analog Scale (VAS)) |
8.25; 8.08; 8.08; 8.17; 8.17; 8.17 | — |
| PRIMARY Perceived Satisfaction (Prosthesis Evaluation Questionnaire (PEQ)) |
7.58; 7.33; 7.17; 7.58; 7.50; 7.33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03828331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.