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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
50
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Becker Orthopedic
Troy, Michigan, United States
RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
ACTIVE_NOT_RECRUITINGOrthocare Innovations, LLC
Edmonds, Washington, United States
RECRUITINGTimed 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.