AFO Prescription to Optimize Post-Stroke Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pre-fabricated (PF) ankle-foot orthosis (AFO)
- Carbon-strut (CS) ankle-foot orthosis (AFO)
- Multifunctional articulating (MA) ankle-foot orthosis (AFO)
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Texas at Austin
Lead sponsor
Medical University of South Carolina
Collaborator
Rancho Los Amigos National Rehabilitation Center
Collaborator
Hanger Clinic: Prosthetics & Orthotics
Collaborator
Brooks Rehabilitation
Collaborator
Source ClinicalTrials.gov