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NCT03651830 · ClinicalTrials.gov registry record · NA
A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
A NA study, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT03651830: Completed NA study, sponsored by Seattle Institute for Biomedical and Clinical Research.
NCT03651830 is a NA study that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651830, a NA study, has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the high or low mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE f
Primary Outcome
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Interventions
- DEVICE Commercially available prosthetic feet
- DEVICE Prosthetic Foot Emulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2022-06-14 |
| Phase | NA |
What the finished NCT03651830 record still lists
NCT03651830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Commercially available prosthetic feet is the first listed.
NCT03651830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03651830 about?
NCT03651830 is a clinical study titled "A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations". Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators a...
What is the current status of trial NCT03651830?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2018-09-24. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT03651830?
The interventions under investigation include: Commercially available prosthetic feet (DEVICE), Prosthetic Foot Emulator (DEVICE).
Who is sponsoring clinical trial NCT03651830?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03651830's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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