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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 is a NA study that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 90 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03651830
The ClinicalTrials.gov registry entry for NCT03651830 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Commercially available prosthetic feet is the first listed.
NCT03651830 reports 0 study locations.
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.
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