Ankle Foot Orthosis (AFO)NCT06692686
AFO Prescription to Optimize Post-Stroke Function
A study testing Pre-fabricated (PF) ankle-foot orthosis (AFO), Carbon-strut (CS) ankle-foot orthosis (AFO) and Multifunctional articulating (MA) ankle-foot orthosis (AFO) in people with Ankle Foot Orthosis (AFO) and Stroke Patients, run by University of Texas at Austin at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Foot Orthosis (AFO), Stroke Patients, Post-Stroke Hemiparesis
- What is being tested?
- Pre-fabricated (PF) ankle-foot orthosis (AFO), Carbon-strut (CS) ankle-foot orthosis (AFO) and Multifunctional articulating (MA) ankle-foot orthosis (AFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jul 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shelby L Walford, PhD contact
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Steve Kautz, PhD, 843-792-3867, kautz@musc.edu
kautz@musc.edu
- Recruiting
Rancho Research Institute
Downey, California, 90242
Jeffery Rankin, PhD, 562-385-7177, jrankin@ranchoresearch.org
jrankin@ranchoresearch.org
- Recruiting
Hanger Clinic
Houston, Texas, 77025
Shane Wurdeman, PhD, 402-290-8051, swurdeman@hanger.com
- Recruiting
Brooks Rehabilitation
Jacksonville, Florida, 32216
Mark Bowden, PhD, 352-318-2779, mark.bowden@Brooksrehab.org
About this study
Official title: 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:
- 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
- Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs.
Read more
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.
- Being tested
- Pre-fabricated (PF) ankle-foot orthosis (AFO), Carbon-strut (CS) ankle-foot orthosis (AFO), Multifunctional articulating (MA) ankle-foot orthosis (AFO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PF-CS-MA | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
| PF-MA-CS | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
| CS-PF-MA | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
| CS-MA-PF | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
| MA-PF-CS | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
| MA-CS-PF | Experimental | 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. Receives: Device: Pre-fabricated (PF) ankle-foot orthosis (AFO); Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
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.
Measured: Over the real-world use period (4 weeks) for each AFO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start8 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle Foot Orthosis (AFO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Rancho Los Amigos National Rehabilitation Center, Hanger Clinic: Prosthetics & Orthotics, Brooks Rehabilitation
- Responsible party
- Principal investigator, Rick Neptune, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692686
- Sponsor's protocol ID
- STUDY00006128
- Other IDs
- CDMRP-OP230030
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Publications
Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65.
PubMed 7996652
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
- ClinicalTrials.gov ID
- NCT06692686
- Acronym / sponsor ID
- STUDY00006128
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Rancho Los Amigos National Rehabilitation Center, Hanger Clinic: Prosthetics & Orthotics, Brooks Rehabilitation
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PF-CS-MA | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
| PF-MA-CS | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
| CS-PF-MA | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
| CS-MA-PF | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
| MA-PF-CS | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
| MA-CS-PF | Experimental | Device: Pre-fabricated (PF) ankle-foot orthosis (AFO), Device: Carbon-strut (CS) ankle-foot orthosis (AFO), Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CS-MA-PF, CS-PF-MA, MA-CS-PF, MA-PF-CS, PF-CS-MA, PF-MA-CS |
| 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 | CS-MA-PF, CS-PF-MA, MA-CS-PF, MA-PF-CS, PF-CS-MA, PF-MA-CS |
| 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. | Device | CS-MA-PF, CS-PF-MA, MA-CS-PF, MA-PF-CS, PF-CS-MA, PF-MA-CS |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 7996652Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shelby L Walford, PhD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-fabricated (PF) ankle-foot orthosis (AFO), Carbon-strut (CS) ankle-foot orthosis (AFO) and Multifunctional articulating (MA) ankle-foot orthosis (AFO) in people with Ankle Foot Orthosis (AFO) and Stroke Patients, run by University of Texas at Austin at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard R Neptune, PhD (512-471-0848, rneptune@mail.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) (time frame: Over the real-world use period (4 weeks) for each AFO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.