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

Phase 2

Recruiting

• Conditions: Stroke
• Interventions: Device: Smart AFO

• Registration Number: NCT05619484
• Lead Sponsor: Orthocare Innovations, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smart AFO	Smart AFO	-

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG) test	Assessed on day 1 (data collection day) with Smart AFO	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.
Ankle power	Assessed on day 1 (data collection day) with Smart AFO	Average peak ankle joint power during stance phase (Newton-meters/second)
Knee angle	Assessed on day 1 (data collection day) with Smart AFO	Average knee joint angle at midstance (degrees)
Knee power	Assessed on day 1 (data collection day) with Smart AFO	Average knee joint power at foot flat after initial contact (Newton-meters/second)
Ankle dorsiflexion	Assessed on day 1 (data collection day) with Smart AFO	Average ankle joint angle during midswing (degrees)
Ankle plantarflexion	Assessed on day 1 (data collection day) with Smart AFO	Average ankle joint angle at foot flat after initial contact (degrees)

Secondary Outcome Measures

Name	Time	Method
Stride length	Assessed on day 1 (data collection day) with Smart AFO	Average stride length of steps (meters)

Trial Locations

Locations (3)

Becker Orthopedic; 🇺🇸 Troy, Michigan, United States

Orthocare Innovations, LLC; 🇺🇸 Edmonds, Washington, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States