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NCT03828331 · ClinicalTrials.gov registry record
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 12
- Enrollment target
NCT03828331: Completed study, sponsored by VA Office of Research and Development.
NCT03828331 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03828331 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
The investigators calculated crank power output (W/kg) from the product of pedal torque and velocity and normalized this to participant body mass while participants rode at 1.5 W/kg using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
Interventions
- OTHER Prosthetic/Bicycle Configuration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2023-08-31 |
What the finished NCT03828331 record still lists
NCT03828331 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Prosthetic/Bicycle Configuration is the first listed.
NCT03828331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03828331 about?
NCT03828331 is a clinical study titled "Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations". 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 ...
What is the current status of trial NCT03828331?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2019-04-01. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT03828331?
The interventions under investigation include: Prosthetic/Bicycle Configuration (OTHER).
Who is sponsoring clinical trial NCT03828331?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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