Ankle-Foot Orthosis for Stroke

Recruiting at 3 trial locations

Overseen By Richard R Neptune, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Severe osteoarthritis, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for people who have had a stroke and experience difficulty with lower-limb movement. It evaluates three different types of ankle-foot orthosis (AFO) devices made from carbon fiber to determine which one best aids walking and balance. Participants will wear each device for a month and complete various tests and questionnaires. The trial suits those who are at least three months post-stroke, can walk at least 20 meters without assistance, and already use an AFO device for mobility outside the house. As an unphased trial, it provides a unique opportunity to explore innovative solutions for enhancing mobility and quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ankle-foot orthosis designs are safe for post-stroke rehabilitation?

Research shows that ankle-foot orthoses (AFOs) are generally safe for people recovering from a stroke. These devices assist with walking by improving balance and foot positioning.

Users have reported high satisfaction with carbon-strut AFOs. Studies comparing carbon AFOs to those made from other materials have not identified any major negative effects, indicating they are well-tolerated.

The multifunctional articulating AFO also appears promising. Research suggests it enhances walking in stroke patients without causing significant safety issues. Its design supports movement and provides stability.

Pre-fabricated AFOs are popular and well-accepted. They may occasionally cause minor skin irritation, but this is a small concern compared to their benefits in improving walking.

Overall, wearing these AFOs is considered safe, with no major adverse events reported in research. Participants in trials have generally tolerated them well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ankle-foot orthosis (AFO) treatments being tested for stroke rehabilitation because they offer innovative approaches to improving mobility. Unlike traditional AFOs, the carbon-strut (CS) AFO provides enhanced energy return and support, potentially making walking more efficient. The multifunctional articulating (MA) AFO allows for a more dynamic range of motion, adapting better to different activities. Additionally, the pre-fabricated (PF) AFO is designed for immediate use without the need for customization, which could streamline the rehabilitation process. These features could lead to improved comfort and functionality for stroke survivors.

What evidence suggests that this trial's ankle-foot orthosis treatments could be effective for stroke rehabilitation?

Research has shown that ankle-foot orthoses (AFOs) can significantly improve walking and balance after a stroke. In this trial, participants will use different AFOs in separate treatment arms. Studies have found that carbon-strut AFOs, one of the options in this trial, reduce pain and improve lower leg function. Multifunctional articulating AFOs, another option, increase walking speed, step length, and balance. Pre-fabricated AFOs, also being tested, enhance walking stability and comfort. Overall, using any of these AFO types after a stroke can improve walking ability and quality of life. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are at least three months post-stroke and have been prescribed an ankle-foot orthosis (AFO) for mobility. Participants should be able to walk 20 meters unassisted and use their AFO daily. They must fall within a specific walking speed range during a test.

Inclusion Criteria

I have been prescribed a specific type of ankle brace.

It has been at least 3 months since my stroke.

I wear my prescribed ankle-foot orthosis (AFO) every day for walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear each of the three modern AFO designs for one month each, after receiving therapy training, and complete questionnaires and performance tests with each AFO.

12 weeks

Multiple visits for therapy training and performance tests

Biomechanical Analysis

A subset of participants perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.

Concurrent with treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbon-strut (CS) ankle-foot orthosis (AFO)
• Multifunctional articulating (MA) ankle-foot orthosis (AFO)
• Pre-fabricated (PF) ankle-foot orthosis (AFO)

Trial Overview The study compares three types of modern carbon fiber AFOs: Pre-fabricated, Carbon-strut, and Multifunctional articulating designs. It aims to determine which design offers the best quality of life by having participants wear each type for one month and complete tests.

How Is the Trial Designed?

Group I: PF-MA-CS Experimental Treatment 3 Interventions

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.

Group II: PF-CS-MA Experimental Treatment 3 Interventions

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.

Group III: MA-PF-CS Experimental Treatment 3 Interventions

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.

Group IV: MA-CS-PF Experimental Treatment 3 Interventions

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.

Group V: CS-PF-MA Experimental Treatment 3 Interventions

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.

Group VI: CS-MA-PF Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

Brooks Rehabilitation Clinical Research Center

Collaborator

Trials

1

Recruited

120+

Rancho Los Amigos National Rehabilitation Center

Collaborator

Trials

10

Recruited

2,000+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345332/

Carbon fiber ankle-foot orthoses in impaired populations Carbon fiber is increasingly being used in ankle-foot orthoses (AFOs). Orthotic devices and carbon fiber-containing devices have been shown to reduce pain ...

2. withpower.com withpower.com/trial/phase-stroke-4-2025-713ec

Ankle-Foot Orthosis for Stroke This trial is for individuals who are at least three months post-stroke and have been prescribed an ankle-foot orthosis (AFO) for mobility. Participants should ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0263822323008863

Effectiveness of 3D printed carbon fiber composite strut in ... The study shows CFS with cAFO is an effective additive manufactured mechanical component for DF patients to improve lower extremity functionality.

4. nsuworks.nova.edu nsuworks.nova.edu/cgi/viewcontent.cgi?article=2242&context=ijahsp

Effect of Posterior Leaf Spring and Carbon Composite ... Paired statistics show that neither PLS-AFO group nor C-AFO group showed better performance at fast walking speed. Page 9. EFFECT OF POSTERIOR LEAF SPRING AND ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01425-7

Customized passive-dynamic ankle–foot orthoses can ... Stiffness-customized PD-AFOs can improve the mechanical cost-of-transport and self-selected walking speed in many individuals post-stroke.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11358842/

EFFECTS OF CARBON VERSUS PLASTIC ANKLE FOOT ... The aim of this study was to explore the difference in walking performance in patients with stroke who have worn a new standard carbon fibre AFO ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980585/

Effects of ankle-foot orthoses on the stability of post-stroke ... The decline in gait performance caused by paretic limb impairments may improve with AFO, which adjusts the alignment and supports paretic ankle stability.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04323943

Comparison of Thermo-plastic Versus Carbon Foot Ankle ... The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on ...