Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO

Study Overview
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Brief Summary
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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.

Official Title
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Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO

Conditions
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Stroke

Intervention / Treatment
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* Device: Smart AFO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Participant's prescribed ankle-foot orthosis<br> | |
| Experimental: Smart AFO<br> | Device: Smart AFO<br>* Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Assessed on day 1 (data collection day) with Smart AFO | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle-foot orthosis, orthotist