What is this study trying to find out about ankle-foot orthosis use after stroke?

This study is evaluating three different ankle-foot orthosis (AFO) designs to see how each affects health-related quality of life and walking function in people after a stroke. The research aims to identify which AFO features best support rehabilitation and daily mobility. It is led by the University of Texas at Austin and focuses on improving post-stroke care.

Who may be eligible for this ankle-foot orthosis clinical trial?

Adults over 18 who are at least three months post-stroke and have been prescribed a semi-rigid or custom articulating AFO may be eligible. Participants must be able to walk at least 20 meters without assistance and wear their AFO for primary mobility outside the home. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this ankle-foot orthosis clinical trial?

Study-related care, including the use of the AFO devices and all trial visits, is provided at no cost. However, participants may need to cover their own travel expenses, which are not guaranteed to be reimbursed. This helps ensure access to the study treatments and assessments without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06692686

Developing Patient-Focused Guidelines for Ankle-Foot Orthosis Use to Improve Function and Quality of Life After Stroke

Led by University of Texas at Austin · Updated on 2025-08-21

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults with lower-limb impairment following a stroke to find the best ankle-foot orthosis AFO design that can improve their health-related quality of life. This clinical trial aims to compare three different modern carbon fiber AFO options and understand how they impact walking and balance. The study will also develop prediction models based on biomechanical function linked to each AFO design to guide clinical prescriptions. Participants will try three different AFO designs in a randomized order, wearing each device for one month after receiving training. The three types of AFOs include a pre-fabricated PF device customized to the patient, a carbon-strut CS AFO molded to the affected limb, and a multifunctional articulating MA AFO with controlled ankle movement. Each participant will follow one of six sequences where they wear each AFO for four weeks, covering all three devices. During the study, participants will complete questionnaires and performance tests with each AFO. A subset will also undergo biomechanical analyses using high-speed cameras and force plates while walking and balancing with each device. Researchers will measure health-related quality of life over the four-week real-world use of each AFO. The study is expected to last until October 2027, with ongoing assessments to understand the impact of each AFO on function and quality of life.

CONDITIONS

Brief Title

AFO Prescription to Optimize Post-Stroke Function

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be at least three months post-stroke
Be older than 18 years
Have been prescribed a semi-rigid or custom-made articulating ankle-foot orthosis (AFO)
Wear the prescribed AFO for all main mobility activities outside the home
Be able to walk at least 20 meters without manual assistance
Walk at least 10 meters per minute during a 6-meter self-selected velocity walking test

You will not qualify if you...

Have a condition significantly limiting walking, such as severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or other neurological disorders besides stroke
Have cognitive problems preventing informed consent
Have an ankle plantar flexion contracture of 15 degrees or more with full knee extension

Research Team

Richard R Neptune, PhD

Shelby L Walford, PhD

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