Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06692686

AFO Prescription to Optimize Post-Stroke Function

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Research Institute, Downey, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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)

Device

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)

Device

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 outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: Over the real-world use period (4 weeks) for each AFO

    Health-related quality of life (HRQoL) is a framework that considers physical, mental, emotional, and social function when assessing the satisfaction of AFO users with their AFO.

Study contacts

Contact information is provided by the study sponsor or research team.

Richard R Neptune, PhD

CONTACT

[email protected]

512-471-0848

Shelby L Walford, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Brooks Rehabilitation
  • Hanger Clinic: Prosthetics & Orthotics
  • Medical University of South Carolina
  • Rancho Los Amigos National Rehabilitation Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.