Actively Recruiting
Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-08
100
Participants Needed
2
Research Sites
N/A
Total Duration
S
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
V
VA Puget Sound Health Care System
Collaborating Sponsor
Researchers are evaluating how different prosthetic feet affect stability and fall-related outcomes in Veterans with below-knee leg amputations. The study aims to improve understanding of how a customizable robotic prosthetic foot emulator (PFE) can help predict which commercial prosthetic feet best support stability, balance confidence, and functional mobility. This research focuses on optimizing prosthetic prescription strategies to enhance quality of life and reduce falls for people with lower leg amputations. Participants will use the multiaxial Prosthetic Foot Emulator, which mimics the mechanical properties of various commercial prosthetic feet, during walking tests on different surfaces like inclines and uneven ground. The study involves a randomized, participant-blinded crossover design where Veterans will test three different foot modes with the PFE and three corresponding actual commercial prosthetic feet. After initial testing, participants will wear each commercial foot at home and in the community for about one week before switching to the next foot. During up to six study visits, participants will complete walking tests, self-report surveys, and performance-based assessments such as the Narrowing Beam Walking Test and Four Square Step Test. Researchers will measure perceived stability, balance confidence, and biomechanical stability outcomes. The study includes both laboratory assessments and real-world use of prosthetic feet, with follow-up testing to evaluate longer-term effects. Total study participation spans multiple weeks with repeated measurements to capture comprehensive stability and functional outcomes.
CONDITIONS
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants walk in the laboratory with the multiaxial Prosthetic Foot Emulator (PFE) in three modes that mimic commercial prosthetic feet under various walking conditions including different speeds, inclines, cross slopes, and uneven terrain.
1 laboratory visit (approximately 2 hours)
Duration - Approximately 3 weeks total (1 week per commercial foot)
Participants walk in the laboratory with three different commercial prosthetic feet under the same walking conditions as with the emulator. Participants are then fit with one of the commercial feet to wear at home and in the community for about one week. This process is repeated for each commercial foot.
3 laboratory visits and community wear periods (approximately 2 hours each laboratory visit, plus home wear)
Duration - Concurrent with the testing period and after each community wear week
Participants return to the laboratory for follow-up testing after each community wear period to assess stability, balance confidence, and functional outcomes using the commercial prosthetic feet.
3 follow-up laboratory visits (approximately 2 hours each)
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
D
David C Morgenroth, MD
E
Elizabeth G Halsne, PhD, CPO
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Tyler K Ho, Elizabeth G Halsne, Sara R Koehler-McNicholas...
https://pubmed.ncbi.nlm.nih.gov/41124130