A Phase 2 interventional study of Smart AFO in Stroke, sponsored by Orthocare Innovations, LLC. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Orthocare Innovations, LLC · Phase 2, Interventional, and Other
The Smart Ankle-Foot Orthosis (Smart AFO) system is an investigational system that combines a diagnostic ankle-foot orthosis with a mobile application to assist clinicians in optimizing an AFO user's gait by adjusting AFO stiffness and range of motion settings, and quantifying functional walking improvements in post-stroke individuals. The purpose of the clinical testing is to evaluate the Smart AFO system with its target users: post-stroke AFO users and orthotists. This may include, but is not limited to, identifying any aspects of the Smart AFO system that could be improved through clinical testing and evaluating the gait of post-stroke AFO users walking with an AFO adjusted using the Smart AFO system.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Orthocare Innovations, LLC is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Smart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Timed Up and Go (TUG) test
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Measured in seconds.
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Timed Up and Go (TUG) test
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Measured in seconds.
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Knee angle
Average knee joint angle at midstance (degrees)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Knee angle
Average knee joint angle at midstance (degrees)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Knee power
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Knee power
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Stride length
Average stride length of steps (meters)
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Stride length
Average stride length of steps (meters)
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orthocare Innovations, LLC