AFO Prescription to Optimize Post-Stroke Function

Part of paid clinical trials in Downey, California.

Sponsor
University of Texas at Austin
Study ID
NCT06692686
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pre-fabricated (PF) ankle-foot orthosis (AFO) — DEVICE
    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.
  • Carbon-strut (CS) ankle-foot orthosis (AFO) — DEVICE
    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.
  • Multifunctional articulating (MA) ankle-foot orthosis (AFO) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: PF-CS-MA
    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.
  • Experimental: PF-MA-CS
    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.
  • Experimental: CS-PF-MA
    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.
  • Experimental: CS-MA-PF
    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.
  • Experimental: MA-PF-CS
    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.
  • Experimental: MA-CS-PF
    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.

Primary Outcome Measure

Health-related quality of life (HRQoL) [ Time Frame: Over the real-world use period (4 weeks) for each AFO ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rancho Research InstituteDowneyCalifornia90242
Jeffery Rankin, PhD
[email protected]
562-385-7177
[email protected]
Brooks RehabilitationJacksonvilleFlorida32216
Mark Bowden, PhD
[email protected]
352-318-2779
Medical University of South CarolinaCharlestonSouth Carolina29425
Steve Kautz, PhD
[email protected]
843-792-3867
[email protected]
Hanger ClinicHoustonTexas77025
Shane Wurdeman, PhD
[email protected]
402-290-8051

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