NCT06692686Recruiting
AFO Prescription to Optimize Post-Stroke Function
The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 8 Jul 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- University of Texas at Austin
- Diseases
- Stroke
- NCT number
- NCT06692686
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 8 Jul 2025 to the primary completion date, Oct 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Rancho Research Institute Coordinator of this site? Confirm its status | Downey | United States | Recruiting |
| Hanger Clinic Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Brooks Rehabilitation Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.