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NCT06692686NARecruiting

AFO Prescription to Optimize Post-Stroke Function

University of Texas at Austin

Start Date

7/8/2025

Completion Date

10/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * be a minimum of three months post-stroke * be greater than 18 years of age * have been prescribed either a semi-rigid or a custom-made articulating AFO * wear their prescribed AFO for all primary mobility activity outside the house * be able to walk at least 20 meters without manual assistance * walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test. Exclusion Criteria: * having a condition that could significantly limit ambulation, including severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or pre-existing neurological disorder other than post-stroke * having cognitive deficits that preclude their ability to provide consent for participation * having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension

Interventions

DEVICE

Pre-fabricated (PF) ankle-foot orthosis (AFO)

DEVICE

Carbon-strut (CS) ankle-foot orthosis (AFO)

DEVICE

Multifunctional articulating (MA) ankle-foot orthosis (AFO)

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Conditions

Ankle Foot Orthosis (AFO)Stroke PatientsPost-Stroke Hemiparesis

Locations

Rancho Research Institute

Downey, California 90242

United States

Brooks Rehabilitation

Jacksonville, Florida 32216

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Hanger Clinic

Houston, Texas 77025

United States