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Search / Trial NCT04338971

Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Launched by NEUROLUTIONS, INC. · Apr 6, 2020

Trial Information

Current as of May 19, 2025

Completed

Keywords

Rehabilitation Brain Computer Interface

ClinConnect Summary

Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 6-months or more post stroke
  • Presentation of upper extremity hemiparesis or hemiplegia
  • Participants must english speaking
  • Demonstrate intact cognition to provide informed consent
  • Botox injections are allowed, and must continue regimen at regular intervals throughout the study
  • Exclusion Criteria -
  • Not active in another clinical study
  • Not receiving formal therapy for the upper extremity
  • No use of other modalities or technologies to the upper extremity
  • Cognitive Impairment: Short Blessed Test Score 9 or above
  • Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow
  • Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally
  • Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use

About Neurolutions, Inc.

Neurolutions, Inc. is a pioneering medical technology company focused on developing innovative solutions for neurological rehabilitation. With a commitment to enhancing the quality of life for individuals with movement disorders, Neurolutions leverages advanced brain-computer interface technology to create groundbreaking therapies that facilitate recovery and improve functional outcomes. The company's research and clinical trials aim to validate the efficacy of its products, providing valuable insights into the intersection of neuroscience and rehabilitation. By collaborating with leading clinical institutions, Neurolutions strives to deliver transformative therapies that empower patients on their journey to regain independence and mobility.

Locations

Santa Cruz, California, United States

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Alexandre Carter, MD, PhD

Principal Investigator

Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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