AFO Prescription to Optimize Post-Stroke Function

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.

Conditions

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

Interventions

DEVICE

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

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

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.

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• Rancho Los Amigos National Rehabilitation Center

  collaborator OTHER

• Hanger Clinic: Prosthetics & Orthotics

  collaborator OTHER

• Brooks Rehabilitation

  collaborator OTHER

• University of Texas at Austin

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-08

Primary Completion

2027-10-31

Completion

2027-10-31

FDA Device

Yes

Countries

• United States

Study Locations