RECRUITING

AFO Prescription to Optimize Post-Stroke Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-08
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06692686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * be a minimum of three months post-stroke
  2. * be greater than 18 years of age
  3. * have been prescribed either a semi-rigid or a custom-made articulating AFO
  4. * wear their prescribed AFO for all primary mobility activity outside the house
  5. * be able to walk at least 20 meters without manual assistance
  6. * walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test.
  1. * 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
  2. * having cognitive deficits that preclude their ability to provide consent for participation
  3. * having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension

Contacts and Locations

Study Contact

Richard R Neptune, PhD
CONTACT
512-471-0848
rneptune@mail.utexas.edu
Shelby L Walford, PhD
CONTACT
shelbywalford@utexas.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-07-08
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Ankle Foot Orthosis (AFO)
  • Stroke Patients
  • Post-Stroke Hemiparesis