AFO Prescription to Optimize Post-Stroke Function

Not Applicable

Not yet recruiting

• Conditions: Ankle Foot Orthosis (AFO); Stroke Patients; Post-Stroke Hemiparesis

• Registration Number: NCT06692686
• Lead Sponsor: University of Texas at Austin

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-29
• Study Start: 2025-05
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 7 days a week
• be able to walk at least 20 meters without manual assistance
• walk at least 10 meters per minute (12% of normal velocity) and no faster than 60 meters per minute (75% 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 one of the brace options be contraindicated for the patient
• 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
• having marked inversion or ankle plantar flexor spasticity that interferes with foot placement for stance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQoL)	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.