CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Prosthetic/Bicycle Configurationother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03828331
NCT03828331N/ACompleted

Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations

VA Office of Research and Development·observational·Posted Feb 4, 2019·Updated Dec 10, 2024

In Brief

An observational study evaluating Prosthetic/Bicycle Configuration for Amputation. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartApr 1, 2019
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.4 years ago

Interventions

Prosthetic/Bicycle Configurationother

The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL.