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NCT05473065 · ClinicalTrials.gov registry record · NA
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
A NA study of Amputation, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05473065 is a NA study of Amputation that is actively recruiting participants, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 100 participants, below the 131-participant average among 65 other Amputation trials with a reported enrollment target (24% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05473065, a NA study of Amputation, is actively recruiting participants, sponsored by Seattle Institute for Biomedical and Clinical Research.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. 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 on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 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 one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 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.
Conditions Studied
Interventions
- DEVICE Multiaxial Prosthetic Foot Emulator
- DEVICE Commercially available prosthetic feet
Study Locations (2)
Minnesota
- Minneapolis VA Medical Center - Minneapolis
Washington
- VA Puget Sound Health Care System - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05473065
The ClinicalTrials.gov registry entry for NCT05473065 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 65 other Amputation trials with a reported enrollment target (24% lower). 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 1 condition, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which Multiaxial Prosthetic Foot Emulator is the first listed.
NCT05473065 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Washington.
Frequently Asked Questions
What is clinical trial NCT05473065 about?
NCT05473065 is a clinical study titled "A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations". Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balanc...
What is the current status of trial NCT05473065?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-03-01. Estimated completion is 2026-07-31.
What conditions does trial NCT05473065 study?
This clinical trial studies the following conditions: Amputation.
What interventions are being tested in trial NCT05473065?
The interventions under investigation include: Multiaxial Prosthetic Foot Emulator (DEVICE), Commercially available prosthetic feet (DEVICE).
Who is sponsoring clinical trial NCT05473065?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05473065 being conducted?
This trial has 2 study locations across Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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