Personalized Prosthetic Foot Prescription and Rehabilitation for Veterans With Lower Limb Loss

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are:

* Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.

Eligibility criteria

Qualifiers

Unilateral transtibial amputation;

At least 6 months post-amputation;

A comfortable-fitting prosthetic socket that can be used with endoskeletal components;

Sufficient walking abilities to safely complete study activities.

Disqualifiers

Major contralateral limb amputation LLL on the contralateral limb;

Currently receiving physical therapy related to gait training or prosthesis use.

Trial design

Treatments tested in this trial

  • Prosthetic foot
  • Physical therapy

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators