Recruiting

AFO Designs

Sponsor:

University of Texas at Austin

Code:

NCT06692686

Conditions

Ankle Foot Orthosis (AFO)

Stroke Patients

Post-Stroke Hemiparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pre-fabricated (PF) ankle-foot orthosis (AFO)

Carbon-strut (CS) ankle-foot orthosis (AFO)

Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Study Details

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:

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

Ankle Foot Orthosis (AFO)

Stroke Patients

Post-Stroke Hemiparesis

Study ID

NCT06692686

Start date

Jul 8, 2025

Status verified date

Aug, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Pre-fabricated (PF) ankle-foot orthosis (AFO)

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.

Carbon-strut (CS) ankle-foot orthosis (AFO)

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.

Multifunctional articulating (MA) ankle-foot orthosis (AFO)

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.

Primary outcome measure

  • Health-related quality of life (HRQoL) [ Time Frame: Over the real-world use period (4 weeks) for each AFO ]

Central Contacts and Locations

Central contacts

Richard R Neptune, PhD

512-471-0848rneptune@mail.utexas.edu

Shelby L Walford, PhD

shelbywalford@utexas.edu

Locations

Rancho Research Institute

Recruiting

Downey, California, United States, 90242

Contacts

Jeffery Rankin, PhD

562-385-7177jrankin@ranchoresearch.org

jrankin@ranchoresearch.org

Brooks Rehabilitation

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Mark Bowden, PhD

352-318-2779mark.bowden@Brooksrehab.org

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Steve Kautz, PhD

843-792-3867kautz@musc.edu

kautz@musc.edu

Hanger Clinic

Recruiting

Houston, Texas, United States, 77025

Contacts

Shane Wurdeman, PhD

402-290-8051swurdeman@hanger.com

More Information

Sponsor

University of Texas at Austin

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-08-21.