Clinical trial NCT06692686: AFO Prescription to Optimize Post-Stroke Function
Official title: The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Foot Orthosis (AFO)
Stroke Patients
Post-Stroke Hemiparesis
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Brooks Rehabilitation Clinical Research Center
name: Rancho Los Amigos National Rehabilitation Center
name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2024-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: Over the real-world use period (4 weeks) for each AFO
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65.