Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.
I B Wilson, P D Cleary
https://pubmed.ncbi.nlm.nih.gov/7996652Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06692686
The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
Led by University of Texas at Austin · Updated on 2025-08-21
120
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas at Austin
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with lower-limb impairment following a stroke to find the best ankle-foot orthosis (AFO) design that can improve their health-related quality of life. This clinical trial aims to compare three different modern carbon fiber AFO options and understand how they impact walking and balance. The study will also develop prediction models based on biomechanical function linked to each AFO design to guide clinical prescriptions. Participants will try three different AFO designs in a randomized order, wearing each device for one month after receiving training. The three types of AFOs include a pre-fabricated (PF) device customized to the patient, a carbon-strut (CS) AFO molded to the affected limb, and a multifunctional articulating (MA) AFO with controlled ankle movement. Each participant will follow one of six sequences where they wear each AFO for four weeks, covering all three devices. During the study, participants will complete questionnaires and performance tests with each AFO. A subset will also undergo biomechanical analyses using high-speed cameras and force plates while walking and balancing with each device. Researchers will measure health-related quality of life over the four-week real-world use of each AFO. The study is expected to last until October 2027, with ongoing assessments to understand the impact of each AFO on function and quality of life.
CONDITIONS
Brief Title
AFO Prescription to Optimize Post-Stroke Function
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Be at least three months post-stroke
- Be older than 18 years
- Have been prescribed a semi-rigid or custom-made articulating ankle-foot orthosis (AFO)
- Wear the prescribed AFO for all main mobility activities outside the home
- Be able to walk at least 20 meters without manual assistance
- Walk at least 10 meters per minute during a 6-meter self-selected velocity walking test
You will not qualify if you...
- Have a condition significantly limiting walking, such as severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or other neurological disorders besides stroke
- Have cognitive problems preventing informed consent
- Have an ankle plantar flexion contracture of 15 degrees or more with full knee extension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Approximately 12 weeks
Participants wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods, following one of several possible sequences of pre-fabricated, carbon-strut, and multifunctional articulating AFOs.
3 treatment periods of 4 weeks each
Trial Site Locations
Total: 4 locations
1
Rancho Research Institute
Downey, California, United States, 90242
Actively Recruiting
2
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
4
Hanger Clinic
Houston, Texas, United States, 77025
Actively Recruiting
Loading map...
Research Team
R
Richard R Neptune, PhD
S
Shelby L Walford, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here