Finding the best ankle-foot brace for stroke recovery
Identifying the Optimal Patient-Specific Dynamic Ankle-Foot Orthosis Bending Stiffness in an Evidence-Based Manner That Can be Implemented by Clinical Providers
This study tests which type of ankle-foot brace works best for stroke survivors to help them walk better by adjusting the support based on their needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06304519 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal bending stiffness of dynamic ankle-foot orthoses (AFOs) for individuals who have experienced a stroke. By customizing the level of assistance provided by these braces based on each patient's ankle impairment, the research seeks to improve walking function. Participants will be evaluated to determine the most effective brace settings, and guidelines will be developed to assist clinicians in prescribing the appropriate AFO for each individual. The study focuses on individuals who have been prescribed an AFO and have specific strength and mobility criteria.
Who should consider this trial
Good fit: Ideal candidates include individuals who are more than six months post-stroke, have been prescribed an AFO, and exhibit specific strength deficits.
Not a fit: Patients with additional neurological conditions, severe mobility limitations, or recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved walking abilities for stroke survivors through personalized brace prescriptions.
How similar studies have performed: Previous studies have indicated that customizing AFOs based on individual needs can enhance walking function, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * chronic stroke (\> 6 months post-stroke) * been prescribed an AFO by a clinician * have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises * have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1). Exclusion Criteria: * Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity.
Where this trial is running
Newark, Delaware
- University of Delaware STAR Campus — Newark, Delaware, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.