AFO Prescription to Optimize Post-Stroke Function

The University of Texas System (UT)

Status: Enrolling

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

Treatments: Device: Carbon-strut (CS) ankle-foot orthosis (AFO); Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO); Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Study type: Interventional

Funder types: Other

Identifiers

NCT06692686

CDMRP-OP230030 (Other Grant/Funding Number)

STUDY00006128

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

PF-CS-MA

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)

PF-MA-CS

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)

CS-PF-MA

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)

CS-MA-PF

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)

MA-PF-CS

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)

MA-CS-PF

Experimental group

Description:

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.

Treatment:

Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)

Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)

Device: Carbon-strut (CS) ankle-foot orthosis (AFO)