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| Name | Class |
|---|---|
| Becker Orthopedic | UNKNOWN |
| University of Utah | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant's prescribed ankle-foot orthosis | No Intervention | ||
| Smart AFO | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart AFO | Device | Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Assessed on day 1 (data collection day) with Smart AFO |
| Ankle plantarflexion | Average ankle joint angle at foot flat after initial contact (degrees) | Assessed on day 1 (data collection day) with prescribed AFO |
| Ankle plantarflexion | Average ankle joint angle at foot flat after initial contact (degrees) | Assessed on day 1 (data collection day) with Smart AFO |
| Ankle power | Average peak ankle joint power during stance phase (Newton-meters/second) | Assessed on day 1 (data collection day) with prescribed AFO |
| Ankle power | Average peak ankle joint power during stance phase (Newton-meters/second) | Assessed on day 1 (data collection day) with Smart AFO |
| Knee angle |
| Measure | Description | Time Frame |
|---|---|---|
| Stride length | Average stride length of steps (meters) | Assessed on day 1 (data collection day) with prescribed AFO |
| Stride length | Average stride length of steps (meters) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Arabian | Contact | 1-425-771-0797 | arabian@orthocareinnovations.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Becker Orthopedic | Recruiting | Troy | Michigan | 48083 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Average knee joint angle at midstance (degrees)
| Assessed on day 1 (data collection day) with prescribed AFO |
| Knee angle | Average knee joint angle at midstance (degrees) | 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) | 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) | Assessed on day 1 (data collection day) with Smart AFO |
| Ankle dorsiflexion | Average ankle joint angle during midswing (degrees) | Assessed on day 1 (data collection day) with prescribed AFO |
| Ankle dorsiflexion | Average ankle joint angle during midswing (degrees) | Assessed on day 1 (data collection day) with Smart AFO |
| Assessed on day 1 (data collection day) with Smart AFO |
| University of Utah | Active, not recruiting | Salt Lake City | Utah | 84108 | United States |
| Orthocare Innovations, LLC | Recruiting | Edmonds | Washington | 98020 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |