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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Troy

Becker Orthopedic, Troy, Michigan, United States, 48083

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84108

Edmonds

Orthocare Innovations, LLC, Edmonds, Washington, United States, 98020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orthocare Innovations, LLC,

Study Record Dates

2024-08-31