Optimizing ankle-foot orthosis choice to improve walking after stroke

The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas at Austin (Academic / other)
• Locations: 4 sites (Downey, California and 3 other locations)
• Trial ID: NCT06692686 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Downey, California and 3 other locations

• 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

Conditions Ankle Foot Orthosis; Stroke Patients; Post-Stroke Hemiparesis