AFO Prescription to Optimize Post-Stroke Function (NCT06692686) | Clinical Trial Compass
RecruitingNot Applicable
AFO Prescription to Optimize Post-Stroke Function
United States120 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health-related quality of life (HRQoL)
Timeframe: Over the real-world use period (4 weeks) for each AFO