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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Pre-fabricated (PF) ankle-foot orthosis (AFO)
DeviceThese pre-manufactured orthoses are customized to fit each patient. These devices can help to distribute weight evenly along the foot, but do not offer much opportunity for adjustment to a patient's specific needs. These AFOs achieve ankle motion through material deflection and lack a single point of articulation.
Carbon-strut (CS) ankle-foot orthosis (AFO)
DeviceThese AFO designs are built from a custom mold of the patient's affected limb for a more individualized fit. It includes a solid ankle design and achieves ankle motion through material deflection and lacks a single point of articulation.
Multifunctional articulating (MA) ankle-foot orthosis (AFO)
DeviceThese AFO designs are also built from a custom mold of the patient's affected limb, but these orthoses have a true articulation at the ankle to provide controlled ankle movement in a range determined appropriate by the orthotist through gait analysis.
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: PF-CS-MAExperimental treatment 3 interventions
Group B: PF-MA-CSExperimental treatment 3 interventions
Group C: CS-PF-MAExperimental treatment 3 interventions
Group D: CS-MA-PFExperimental treatment 3 interventions
Group E: MA-PF-CSExperimental treatment 3 interventions
Group F: MA-CS-PFExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) is a framework that considers physical, mental, emotional, and social function when assessing the satisfaction of AFO users with their AFO.
Time frame
Over the real-world use period (4 weeks) for each AFOSponsors and contacts
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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