Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06692686

AFO Prescription to Optimize Post-Stroke Function

Led by University of Texas at Austin · Updated on 2025-08-21

120

Participants Needed

4

Research Sites

116 weeks

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

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.

CONDITIONS

Official Title

AFO Prescription to Optimize Post-Stroke Function

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
  • Wear the prescribed ankle-foot orthosis for all main mobility activities outside the home
  • Be able to walk at least 20 meters without manual help
  • Walk at least 10 meters per minute during a 6-meter self-selected walking test
Not Eligible

You will not qualify if you...

  • Have a condition significantly limiting walking, such as severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or neurological disorders other than post-stroke
  • Have cognitive problems that prevent giving consent for participation
  • 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

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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

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Research Team

R

Richard R Neptune, PhD

CONTACT

S

Shelby L Walford, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

6

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