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AFO Prescription to Optimize Post-Stroke Function

Key facts

Where
Charleston, Downey, Houston, and Jacksonville, United StatesSee the 4 sites

Where in United States

  • Medical University of South CarolinaCharleston, United StatesTaking people
  • Rancho Research InstituteDowney, United StatesTaking people
  • Hanger ClinicHouston, United StatesTaking people
  • Brooks RehabilitationJacksonville, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Texas at Austin
Trial code
NCT06692686
Record updated
21 August 2025
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06692686