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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID05473065

Testing Prosthetic Foot Designs to Improve Stability and Reduce Falls in Veterans With Below-Knee Amputations

Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-08

100

Participants Needed

2

Research Sites

N/A

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

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

Brief Title

A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

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 feet
  • Able to walk with a prosthetic limb sufficiently to participate in walking trials
Not Eligible

You will not qualify if you...

  • Having contralateral limb or upper limb amputation interfering with study activities
  • Unable to use more than one of the test feet for any reason
  • Unable to walk under minimal study walking conditions without undue stress
  • Current surgical, neurological, rheumatologic, or lower limb musculoskeletal problems that impair walking
  • Weighing more than 263 pounds
  • Inadequate cognitive or language function to consent
  • Currently incarcerated
  • Impaired decision-making ability or requiring a legally authorized representative

Research Team

D

David C Morgenroth, MD

E

Elizabeth G Halsne, PhD, CPO

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