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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Rancho Research Institute
RECRUITING
Downey
Florida
Brooks Rehabilitation
RECRUITING
Jacksonville
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Hanger Clinic
RECRUITING
Houston
Contact Information
Primary
Richard R Neptune, PhD
rneptune@mail.utexas.edu
512-471-0848
Backup
Shelby L Walford, PhD
shelbywalford@utexas.edu
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2027-10
Participants
Target number of participants: 120
Treatments
Experimental: PF-CS-MA
Participants 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.
Experimental: PF-MA-CS
Participants 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.
Experimental: CS-PF-MA
Participants 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.
Experimental: CS-MA-PF
Participants 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.
Experimental: MA-PF-CS
Participants 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.
Experimental: MA-CS-PF
Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: Hanger Clinic: Prosthetics & Orthotics, Medical University of South Carolina, Rancho Los Amigos National Rehabilitation Center, Brooks Rehabilitation
Leads: University of Texas at Austin

This content was sourced from clinicaltrials.gov