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

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.

Inclusion Criteria:Age 18 years or olderMass less than 90 kg (200 lbs)At least six months post-strokeHemiplegia or hemiparesis as a result of strokeFoot drop during swing phase (often identified by a toe catch), on at least one sideCurrent user of an AFOCurrent user of an AFO with a Triple Action Joint is acceptableHas bilateral passive ankle range of motion within normal limitsAble to walk safely on level ground for at least 100 feet without restAble to communicate individual perceptions in the English languageAble to provide written informed consentParticipants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmillExclusion Criteria:Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participationPregnancyNot able to read and understand EnglishUse of assistive device that requires bilateral upper extremities