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

Last updated: October 6, 2023
Sponsor: Orthocare Innovations, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Cerebral Ischemia

Stroke

Treatment

Smart AFO

Clinical Study ID

NCT05619484
0019-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 towalk independently and safely on an instrumented treadmill

Exclusion

Exclusion Criteria:

  • Confounding injury, musculoskeletal issues, or cognitive issues that limit effectiveparticipation
  • Pregnancy
  • Not able to read and understand English
  • Use of assistive device that requires bilateral upper extremities

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Smart AFO
Phase: 2
Study Start date:
August 15, 2022
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Becker Orthopedic

    Troy, Michigan 48083
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Orthocare Innovations, LLC

    Edmonds, Washington 98020
    United States

    Active - Recruiting

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