Clinical Trial

AFO Prescription to Optimize Post-Stroke Function

Recruiting
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Summary
The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will: 1. Identify the factors that significantly contribute to an individual's highest potential quality of life when considering each of the three available AFO design options, and 2. Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs. Participants will be asked to: * Wear each of the three modern AFO designs for one month, after receiving therapy training and * Complete questionnaires and performance tests with each AFO. In addition, the subset of individuals participating in goal 2) will also be asked to: * Perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-14; most recent amendment 2025-08-15.
Status change: Not Yet Recruiting → Recruiting 2025-08-15
Trial Details
NCT Number NCT06692686
Lead Sponsor University of Texas at Austin
Collaborators: Medical University of South Carolina, Rancho Los Amigos National Rehabilitation Center, Hanger Clinic: Prosthetics & Orthotics, Brooks Rehabilitation
Conditions Ankle Foot Orthosis (AFO), Stroke Patients, Post-Stroke Hemiparesis
Enrollment 120 participants
Start Date 2025-07-08
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2025-08-21