Smart Ankle-Foot Orthosis to help improve walking after stroke
Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
This study is testing a new ankle-foot brace with a mobile app to see if it can help people who have had a stroke walk better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthocare Innovations, LLC Industry-sponsored |
| Locations | 3 sites (Troy, Michigan and 2 other locations) |
| Trial ID | NCT05619484 on ClinicalTrials.gov |
What this trial studies
The Smart Ankle-Foot Orthosis (Smart AFO) system is designed to assist post-stroke individuals by optimizing their gait through a combination of a diagnostic ankle-foot orthosis and a mobile application. This system allows clinicians to adjust the stiffness and range of motion settings of the AFO, while also quantifying improvements in walking functionality. The clinical testing aims to evaluate the effectiveness of the Smart AFO in enhancing gait for users and to identify potential areas for improvement in the system. Participants will include individuals who have experienced a stroke and are current users of an AFO.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are at least six months post-stroke and currently use an ankle-foot orthosis.
Not a fit: Patients with confounding injuries, cognitive issues, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance walking ability and overall mobility for post-stroke patients.
How similar studies have performed: Other studies have shown promise in using adaptive orthotic devices for improving mobility in stroke patients, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Mass less than 90 kg (200 lbs) * At least six months post-stroke * Hemiplegia or hemiparesis as a result of stroke * Foot drop during swing phase (often identified by a toe catch), on at least one side * Current user of an AFO * Current user of an AFO with a Triple Action Joint is acceptable * Has bilateral passive ankle range of motion within normal limits * Able to walk safely on level ground for at least 100 feet without rest * Able to communicate individual perceptions in the English language * Able to provide written informed consent * Participants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmill Exclusion Criteria: * Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation * Pregnancy * Not able to read and understand English * Use of assistive device that requires bilateral upper extremities
Where this trial is running
Troy, Michigan and 2 other locations
- Becker Orthopedic — Troy, Michigan, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Active_not_recruiting)
- Orthocare Innovations, LLC — Edmonds, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Adam Arabian
- Email: arabian@orthocareinnovations.com
- Phone: 1-425-771-0797
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.