RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-15
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05619484

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Mass less than 90 kg (200 lbs)
  3. * At least six months post-stroke
  4. * Hemiplegia or hemiparesis as a result of stroke
  5. * Foot drop during swing phase (often identified by a toe catch), on at least one side
  6. * Current user of an AFO
  7. * Current user of an AFO with a Triple Action Joint is acceptable
  8. * Has bilateral passive ankle range of motion within normal limits
  9. * Able to walk safely on level ground for at least 100 feet without rest
  10. * Able to communicate individual perceptions in the English language
  11. * Able to provide written informed consent
  12. * Participants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmill
  1. * Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation
  2. * Pregnancy
  3. * Not able to read and understand English
  4. * Use of assistive device that requires bilateral upper extremities

Contacts and Locations

Study Contact

Adam Arabian
CONTACT
1-425-771-0797
arabian@orthocareinnovations.com

Study Locations (Sites)

Becker Orthopedic
Troy, Michigan, 48083
United States
University of Utah
Salt Lake City, Utah, 84108
United States
Orthocare Innovations, LLC
Edmonds, Washington, 98020
United States

Collaborators and Investigators

Sponsor: Orthocare Innovations, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-15
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

  • ankle-foot orthosis
  • orthotist

Additional Relevant MeSH Terms

  • Stroke