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

Orthocare Innovations

Status and phase: Enrolling; Phase 2

Conditions: Stroke

Treatments: Device: Smart AFO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05619484

0019-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Participant's prescribed ankle-foot orthosis

No Intervention group

Smart AFO

Experimental group

Treatment:

Device: Smart AFO