AFO Prescription to Optimize Post-Stroke Function
The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
2 other identifiers
interventional
120
1 country
4
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
July 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
August 21, 2025
August 1, 2025
2.2 years
November 7, 2024
August 15, 2025
Conditions
Outcome Measures
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.
Over the real-world use period (4 weeks) for each AFO
Study Arms (6)
PF-CS-MA
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO.
PF-MA-CS
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO.
CS-PF-MA
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO.
CS-MA-PF
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO.
MA-PF-CS
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO.
MA-CS-PF
EXPERIMENTALParticipants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas at Austinlead
- Medical University of South Carolinacollaborator
- Rancho Los Amigos National Rehabilitation Centercollaborator
- Hanger Clinic: Prosthetics & Orthoticscollaborator
- Brooks Rehabilitationcollaborator
Study Sites (4)
Rancho Research Institute
Downey, California, 90242, United States
Brooks Rehabilitation
Jacksonville, Florida, 32216, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Hanger Clinic
Houston, Texas, 77025, United States
Related Publications (1)
Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65.
PMID: 7996652BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 18, 2024
Study Start
July 8, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Final research de-identified data generated from this project will be made available to the research community upon request. Data requests may be subject to a signed data user agreement (DUA).