Prosthetic Foot + Physical Therapy for Leg Amputation
(OPORP Trial)
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Personalized Prosthetic Foot Prescription and Rehabilitation for leg amputation?
Is the combination of a prosthetic foot and physical therapy safe for people with leg amputations?
How is the Personalized Prosthetic Foot Prescription treatment different from other treatments for leg amputation?
The Personalized Prosthetic Foot Prescription is unique because it involves customizing the prosthetic foot to match the individual's lifestyle and functional needs, which can include adjustable and sophisticated designs. This personalized approach ensures that the prosthetic foot is well-suited to the patient's specific requirements, unlike standard prosthetic options that may not offer such tailored adjustments.510111213
Eligibility Criteria
This trial is for Veterans and others with a single below-knee amputation that happened at least 6 months ago. They must have a well-fitting prosthetic socket and be able to walk safely for the study activities. People with an amputation on the other leg or those currently in physical therapy for walking or prosthesis use can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Prosthesis Condition Selection
Participants experience walking with three prosthesis conditions and select their most and least preferred foot
Accommodation Period
Participants undergo a community-based accommodation period with their most preferred commercial foot
Physical Therapy Intervention
Participants receive either the standard-of-care or an eight-week personalized physical therapy intervention
Follow-up
Participants are monitored for satisfaction, mobility, and balance after the intervention
Treatment Details
Interventions
- Personalized Prosthetic Foot Prescription
- Rehabilitation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor