Optimizing ankle-foot orthosis choice to improve walking after stroke
Official title: The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
Run by University of Texas at Austin · NCT06692686 · Data updated 2026-11-12
People at least three months after a stroke will try three modern carbon-fiber ankle-foot orthoses for one month each to see which helps walking, function, and quality of life the most.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 4 sites (Downey, California and 3 other locations) |
| Status | Recruiting |
| Started | July 8, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | August 21, 2025 |
| Trial ID | NCT06692686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults more than three months post-stroke who have been prescribed a semi-rigid or custom articulating AFO, wear their AFO for primary mobility outside the home, can walk at least 20 meters without manual assistance, and walk at least 10 meters per minute on a self-selected test.
✕Probably not a fit
Patients with other major conditions that severely limit walking, significant cognitive impairment preventing consent, or an ankle plantar flexion contracture ≥15 degrees are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants receive training and then wear each of three modern AFO designs (pre-fabricated, carbon-strut, and multifunctional articulating) for one month while completing questionnaires and performance walking tests. A subset also completes detailed biomechanical testing with high-speed cameras and force plates to link gait mechanics to AFO performance. Investigators will identify factors that predict which AFO design yields the best patient-reported quality of life and build prediction models based on clinical and biomechanical data. The aim is to create tools that help clinicians match individuals to the AFO most likely to improve their mobility and daily function.
Why it matters
Potential benefit: If successful, this work could help clinicians pick the AFO design most likely to improve an individual patient's walking and quality of life after stroke.
How similar studies have gone: Prior studies have shown carbon-fiber AFOs can improve gait in people post-stroke, but using biomechanical prediction models to match individuals to one of several modern AFO designs is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Rancho Research Institute
Downey, California, United States Recruiting -
Brooks Rehabilitation
Jacksonville, Florida, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Hanger Clinic
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Richard R Neptune, PhD
- Email: rneptune@mail.utexas.edu
- Phone: 512-471-0848
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.