Testing a new prosthetic foot to improve stability for veterans with leg amputations
A Prosthetic Foot Test-Drive Strategy for Improving Stability and Falls-Related Outcomes in Veterans With Leg Amputations
NA · Seattle Institute for Biomedical and Clinical Research · NCT05473065
This study is testing different types of prosthetic feet to see which ones help veterans with leg amputations feel more stable and confident when walking.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Seattle Institute for Biomedical and Clinical Research (other) |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT05473065 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of different commercial prosthetic feet on stability and fall-related outcomes in veterans with below-knee amputations. Participants will use a customizable robotic prosthetic foot emulator to test various foot designs in a controlled environment. The study will involve a participant-blinded cross-over design with repeated measurements, allowing veterans to experience multiple prosthetic options during their visits. The goal is to identify which prosthetic feet enhance balance and confidence in walking.
Who should consider this trial
Good fit: Ideal candidates are veterans with a unilateral transtibial amputation who have been using a prosthetic limb for at least six months.
Not a fit: Patients with additional limb amputations or those unable to use multiple test feet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stability and reduced fall risk for veterans using prosthetic limbs.
How similar studies have performed: Other studies have shown promise in using customizable prosthetic devices to improve mobility outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * has a unilateral (one leg) transtibial (below-knee) amputation * has used a prosthetic limb for walking for at least six months * has a comfortably fitting prosthetic socket * has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet * be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials Exclusion Criteria: * contralateral limb or upper limb amputation that would interfere with completion of study activities * are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet) * unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress * current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness) * weight greater than 263lbs. * inadequate cognitive or language function to consent to participate * currently incarcerated * impaired decision-making ability or the use of a legally authorized representative
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- Minneapolis VA Medical Center — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
- VA Puget Sound Health Care System — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: David C Morgenroth, MD — VA Puget Sound Health Care System
- Study coordinator: David C Morgenroth, MD
- Email: dmorgen@uw.edu
- Phone: 206-277-1982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, amputation, rehabilitation, balance, stability, falls, emulator, prosthetics