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NCT03625921 · ClinicalTrials.gov registry record · NA
Transfemoral Powered Foot and Physical Therapy Study
A NA study of Prosthesis User and Lower Extremity Problem, sponsored by VA New York Harbor Healthcare System.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03625921: Active NA study of Prosthesis User and Lower Extremity Problem, sponsored by VA New York Harbor Healthcare System.
NCT03625921 is a NA study of Prosthesis User and Lower Extremity Problem that is active but no longer recruiting, run by VA New York Harbor Healthcare System. The registered enrollment target is 20 participants, below the 56-participant average among 12 other Prosthesis User trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03625921, a NA study of Prosthesis User and Lower Extremity Problem, is active but no longer recruiting, sponsored by VA New York Harbor Healthcare System.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.
Primary Outcome
Biomechanical evaluation of gait with 3D motion capture while the individual is walking at several different speeds.
Conditions Studied
Interventions
- BEHAVIORAL Powered device with physical therapy
- BEHAVIORAL Powered device with standard of practice
Study Locations (1)
New York
- VA New York Harbor Healthcare System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2026-01-14 |
| Phase | NA |
What the registry record for NCT03625921 still lists
NCT03625921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 56-participant average among 12 other Prosthesis User trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Prosthesis User appearing as the primary indexed condition, and to 2 interventions - of which Powered device with physical therapy is the first listed.
NCT03625921 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03625921 about?
NCT03625921 is a clinical study titled "Transfemoral Powered Foot and Physical Therapy Study". Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functiona...
What is the current status of trial NCT03625921?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2017-11-17. Estimated completion is 2026-01-14.
What conditions does trial NCT03625921 study?
This clinical trial studies the following conditions: Prosthesis User, Lower Extremity Problem.
What interventions are being tested in trial NCT03625921?
The interventions under investigation include: Powered device with physical therapy (BEHAVIORAL), Powered device with standard of practice (BEHAVIORAL).
Who is sponsoring clinical trial NCT03625921?
This trial is sponsored by VA New York Harbor Healthcare System, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03625921 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03625921's enrollment target sits among peer trials
20 7th of 12 higher than 6 of 12 other Prosthesis User trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prosthesis User trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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