NCT05619484

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Orthocare Innovations, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Smart AFO	Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application

Timeline

• Start date: 2022-08-15
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-11-17
• Last updated: 2023-10-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study