AFO Prescription to Optimize Post-Stroke Function

August 15, 2025 updated by: Rick Neptune, University of Texas at Austin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
    • Florida
      • Jacksonville, Florida, United States, 32216
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77025
        • Recruiting
        • Hanger Clinic
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Device: 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.
Device: 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.
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.
Device: 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.
Device: 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.
Device: 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.
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.
Device: 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.
Device: 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.
Device: 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.
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.
Device: 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.
Device: 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.
Device: 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.
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.
Device: 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.
Device: 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.
Device: 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.
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.
Device: 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.
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over the real-world use period (4 weeks) for each AFO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006128
  • CDMRP-OP230030 (Other Grant/Funding Number: DoD - USAMRAA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Final research de-identified data generated from this project will be made available to the research community upon request. Data requests may be subject to a signed data user agreement (DUA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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