NCT06692686 AFO Prescription to Optimize Post-Stroke Function
| NCT ID | NCT06692686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Ankle Foot Orthosis (AFO) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-07-08 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06692686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankle Foot Orthosis (AFO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692686 currently recruiting?
Yes, NCT06692686 is actively recruiting participants. Contact the research team at rneptune@mail.utexas.edu for enrollment information.
Where is the NCT06692686 trial being conducted?
This trial is being conducted at Downey, United States, Jacksonville, United States, Charleston, United States, Houston, United States.
Who is sponsoring the NCT06692686 clinical trial?
NCT06692686 is sponsored by University of Texas at Austin. The trial plans to enroll 120 participants.