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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619484
• Other study ID #: 0019-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Orthocare Innovations, LLC
• Contact: Adam Arabian
• Phone: 1-425-771-0797
• Email: arabian[@]orthocareinnovations.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Smart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington
United States	University of Utah	Salt Lake City	Utah
United States	Becker Orthopedic	Troy	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	Becker Orthopedic, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG) test	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.	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Timed Up and Go (TUG) test	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.	Assessed on day 1 (data collection day) with Smart AFO
Primary	Ankle plantarflexion	Average ankle joint angle at foot flat after initial contact (degrees)	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Ankle plantarflexion	Average ankle joint angle at foot flat after initial contact (degrees)	Assessed on day 1 (data collection day) with Smart AFO
Primary	Ankle power	Average peak ankle joint power during stance phase (Newton-meters/second)	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Ankle power	Average peak ankle joint power during stance phase (Newton-meters/second)	Assessed on day 1 (data collection day) with Smart AFO
Primary	Knee angle	Average knee joint angle at midstance (degrees)	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Knee angle	Average knee joint angle at midstance (degrees)	Assessed on day 1 (data collection day) with Smart AFO
Primary	Knee power	Average knee joint power at foot flat after initial contact (Newton-meters/second)	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Knee power	Average knee joint power at foot flat after initial contact (Newton-meters/second)	Assessed on day 1 (data collection day) with Smart AFO
Primary	Ankle dorsiflexion	Average ankle joint angle during midswing (degrees)	Assessed on day 1 (data collection day) with prescribed AFO
Primary	Ankle dorsiflexion	Average ankle joint angle during midswing (degrees)	Assessed on day 1 (data collection day) with Smart AFO
Secondary	Stride length	Average stride length of steps (meters)	Assessed on day 1 (data collection day) with prescribed AFO
Secondary	Stride length	Average stride length of steps (meters)	Assessed on day 1 (data collection day) with Smart AFO