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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Seattle Institute for Biomedical and Clinical Research
Study ID
NCT05473065
Status
Recruiting
Apply to this trial

Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Multiaxial Prosthetic Foot Emulator — DEVICE
    Participants will walk in the laboratory with the multiaxial Prosthetic Foot Emulator (PFE) in three foot modes corresponding to commercial prosthetic study feet. Walking conditions will include self-selected comfortable, slow, and fast speeds, inclines, cross slopes, and uneven terrain.
  • Commercially available prosthetic feet — DEVICE
    Participants will walk in the laboratory with the commercial prosthetic study feet in three foot modes corresponding to commercial prosthetic study feet. Walking conditions will include self-selected comfortable, slow, and fast speeds, inclines, cross slopes, and uneven terrain. Additionally, participants will be fit with one of the commercial prosthetic study feet and wear it at home and in the community for approximately one week. Participants will return to the laboratory to follow-up testing, and will complete the community trial with each of the three commercial prosthetic study feet.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Multiaxial Prosthetic Foot Emulator (PFE)
    The multiaxial Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how prosthesis users will respond to candidate feet. Participants will walk with the PFE using three different modes (emulating three commercial feet) under different walking conditions.
  • Active Comparator: Commercially available prosthetic feet
    Participants will walk under different walking conditions using three different commercial prosthetic feet.

Primary Outcome Measure

Self-report: perceived stability [ Time Frame: Administered at baseline and during follow up testing with the commercial feet (approximately 2 hours) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Minneapolis VA Medical CenterMinneapolisMinnesota55417
Sara Koehler-McNicholas, PhD
[email protected]
(612) 467-4017
VA Puget Sound Health Care SystemSeattleWashington98108
David C Morgenroth, MD
[email protected]
206-277-1982

Find similar trials in Minneapolis, MN

By research site
Minneapolis VA Medical Center· Minneapolis, MNVA Puget Sound Health Care System· Seattle, WA

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