Ankle Foot Orthosis (AFO), Post-Stroke Hemiparesis, Stroke Patients
Conditions
Brief 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.
Interventions
DEVICEPre-fabricated (PF) ankle-foot orthosis (AFO)
These 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.
DEVICECarbon-strut (CS) ankle-foot orthosis (AFO)
These 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.
DEVICEMultifunctional articulating (MA) ankle-foot orthosis (AFO)
These 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.
Sponsors
Medical University of South Carolina
Rancho Los Amigos National Rehabilitation Center
Hanger Clinic: Prosthetics & Orthotics
Brooks Rehabilitation
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (HRQoL) | Over the real-world use period (4 weeks) for each AFO | 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. |
Countries
United States
Contacts
Primary ContactRichard R Neptune, PhD
Backup ContactShelby L Walford, PhD
Outcome results
None listed