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Status:

COMPLETED

Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Lead Sponsor:

Neurolutions, Inc.

Conditions:

Stroke

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. Th...

Detailed Description

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 5 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 9 2020

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT04338971

    Start Date

    May 5 2017

    End Date

    October 9 2020

    Last Update

    January 18 2022

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Neurolutions

    Santa Cruz, California, United States, 95060

    2

    Neurolutions

    St Louis, Missouri, United States, 63110