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

Status unconfirmed · Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT05619484

Run by

Orthocare Innovations, LLC

People needed

50

Starts

2022-08-15

Expected to finish

2024-08-31

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Becker Orthopedic — Troy, Michigan, United States (enrolling)
• Orthocare Innovations, LLC — Edmonds, Washington, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.