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NCT06844305
Personalized Prosthetic Foot Prescription and Rehabilitation for Veterans With Lower Limb Loss
Conditions: Amputation of Lower Limb
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Northwestern University
Location: Northwestern University Prosthetics-Orthotics Center Chicago Illinois
Summary
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Major contralateral limb amputation LLL on the contralateral limb;
* Currently receiving physical therapy related to gait training or prosthesis use.
Source: ClinicalTrials.gov (NCT06844305). StuddyBuddy aggregates publicly available trial information.