Actively Recruiting
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-08
100
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
Sponsors
S
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
V
VA Puget Sound Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 allowing use with study prosthetic feet
- Is able to walk with a prosthetic limb sufficiently to participate in walking trials
You will not qualify if you...
- Has a contralateral limb or upper limb amputation interfering with study activities
- Unable to use more than one of the test feet (e.g., due to residual limb length)
- Unable to walk under minimum study walking conditions without undue stress
- Has current surgical, neurological, rheumatologic, or lower limb musculoskeletal problems that significantly impair walking
- Weighs more than 263 lbs
- Has inadequate cognitive or language function to consent
- Is currently incarcerated
- Has impaired decision-making ability or requires a legally authorized representative
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Not Yet Recruiting
2
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
D
David C Morgenroth, MD
CONTACT
E
Elizabeth G Halsne, PhD, CPO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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