Stroke
Conditions
Keywords
ankle-foot orthosis, orthotist
Brief summary
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.
Interventions
DEVICESmart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Sponsors
Becker Orthopedic
University of Utah
Orthocare Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle power | Assessed on day 1 (data collection day) with prescribed AFO | Average peak ankle joint power during stance phase (Newton-meters/second) |
| Timed Up and Go (TUG) test | Assessed on day 1 (data collection day) with prescribed AFO | 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. |
| Ankle plantarflexion | Assessed on day 1 (data collection day) with prescribed AFO | Average ankle joint angle at foot flat after initial contact (degrees) |
| Ankle dorsiflexion | Assessed on day 1 (data collection day) with prescribed AFO | Average ankle joint angle during midswing (degrees) |
| Knee angle | Assessed on day 1 (data collection day) with prescribed AFO | Average knee joint angle at midstance (degrees) |
| Knee power | Assessed on day 1 (data collection day) with prescribed AFO | Average knee joint power at foot flat after initial contact (Newton-meters/second) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stride length | Assessed on day 1 (data collection day) with prescribed AFO | Average stride length of steps (meters) |
Countries
United States
Contacts
Primary ContactAdam Arabian
Outcome results
None listed