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Search / Trial NCT05619484

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

Launched by ORTHOCARE INNOVATIONS, LLC · Nov 11, 2022

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Ankle Foot Orthosis Orthotist

ClinConnect Summary

The Smart AFO study is testing a new type of ankle-foot brace designed to help people who have had a stroke improve their walking. This system combines a special brace with a mobile app that helps doctors adjust the brace to better support the user’s needs. The goal is to see how well this system can improve walking abilities in stroke survivors who currently use an ankle-foot orthosis (AFO), which is a device that helps lift the foot during walking.

To participate in this study, individuals must be at least 18 years old, weigh less than 200 pounds, and have experienced a stroke at least six months prior. They should also have difficulty lifting their foot (known as foot drop) and be able to walk safely for at least 100 feet without stopping. Participants will work with the Smart AFO system to see how it can help them walk better. If you're considering joining the trial, you'll need to be able to communicate your experiences in English and give your written consent to participate. This study is currently seeking participants, and it offers a unique opportunity to help improve walking aids for stroke recovery.

Gender

ALL

Eligibility criteria

  • 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

About Orthocare Innovations, Llc

Orthocare Innovations, LLC is a leading clinical trial sponsor specializing in the development and commercialization of advanced orthopedic technologies. Focused on enhancing patient outcomes, the company leverages innovative research and cutting-edge methodologies to create solutions that address critical challenges in musculoskeletal health. With a commitment to scientific rigor and ethical standards, Orthocare Innovations collaborates with healthcare professionals and research institutions to conduct clinical trials that pave the way for transformative therapies in orthopedic care. Their expertise extends across various therapeutic areas, emphasizing the importance of evidence-based practices in improving patient quality of life.

Locations

Edmonds, Washington, United States

Salt Lake City, Utah, United States

Troy, Michigan, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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