IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

Not Applicable

Withdrawn

• Conditions: Hemiparesis; Stroke
• Interventions: Device: IpsiHand Treatment

• Registration Number: NCT04123808
• Lead Sponsor: Columbia University

Brief Summary

This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.

Detailed Description

This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-12-02
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)

• PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs

• English speaking

• Intact cognition to provide informed consent

• Intact language skills to comprehend and follow directions

• Experiencing difficulty performing ADLs with affected upper limb

• Upper extremity Botox allowable, but not required

  • Botox users must continue regimen at regular intervals for duration of study
  • Botox users will provide clinic note for each injection (date, dose, and muscle location)
  • Botox + Study Schedule

• At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use

• Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures

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Exclusion Criteria

• Concurrent participation in another study
• Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
• History of neurological disorder other than stroke
• Botox user unable to comply with above noted requirements
• Ongoing physical or occupational therapy addressing the upper limb
• Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
• Cognitive impairment: Short Blessed Test Score 9
• Significant spasticity: Modified Ashworth Scale score 3 at the elbow
• Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
• Insufficient Strength: Motricity Index score for shoulder abduction 18
• Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
• History of cranioplasty
• History of seizure disorder
• No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IpsiHand Treatment	IpsiHand Treatment	All participants will receive treatment with IpsiHand device

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity	Baseline through 3 months post no device use	The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	Baseline through 3 months post no device use	The ARAT is a scale that measures activity participation of the arm. There are 19 items that several types of grasps, grips, pinches, and gross movements of the arm and hand. Each item is scored from 0-3, with a maximum total score of 57. Higher scores indicate better performance.
Box and Block Test	Baseline through 3 months post no device use	The Box and Block Test measures the number of blocks a participant can pick up and place over a patrician in 1 minute. The number of blocks successfully moved are counted and a higher number indicates better performance.