- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123808
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
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.
Sponsor
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.
General Publications
- Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
- Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.
- Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS4076
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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