IpsiHand System for Rehabilitation of the Arm and Hand After Stroke

August 4, 2020 updated by: Joel Stein, MD, Columbia University

Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IpsiHand Treatment
All participants will receive treatment with IpsiHand device
The IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
Time Frame: 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.
Baseline through 3 months post no device use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 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.
Baseline through 3 months post no device use
Box and Block Test
Time Frame: 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.
Baseline through 3 months post no device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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