Status:

RECRUITING

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

Lead Sponsor:

Seattle Institute for Biomedical and Clinical Research

Collaborating Sponsors:

VA Puget Sound Health Care System

Minneapolis Veterans Affairs Medical Center

Conditions:

Amputation

Eligibility:

All Genders

18-89 years

Phase:

NA

Brief 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 Veteran...

Detailed Description

Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and people with limb loss suffer from a wide range of mobility lim...

Eligibility 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

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05473065

Start Date

March 1 2024

End Date

July 31 2026

Last Update

September 8 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States, 55417

2

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108