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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06844305). StuddyBuddy aggregates publicly available trial information.