Safety and Feasibility of eGlove
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Event related desynchronization measurement
Sponsored by

About this trial
This is an interventional basic science trial for Stroke focused on measuring Upper Extremity, Body Computer Interface
Eligibility Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic stroke (6 months post stroke)
- Hemiparesis
- Some degree of hand and finger movement capability
- a moderate impairment (Fugl-Meyer score between 15-50)
Exclusion Criteria:
- Individuals under the age of 18
- Bilateral paresis
- Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)
- Botox injection to the affected upper extremity within the previous 4 months
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Measuring neural activity
Arm Description
While completing hand opening/closing, individuals will have the following measured (1) Neural activity (specifically sensorimotor rhythms) using a EEG cap; (2) muscle activity (specifically finger flexors and extensors) using EMG sensors.
Outcomes
Primary Outcome Measures
Rate of activation of Event Related Desynchronization
Sensorimotor neural activity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05345301
Brief Title
Safety and Feasibility of eGlove
Official Title
Electroencephalographic Correlates of Glove-stretch Therapy Post-stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
September 14, 2022 (Actual)
Study Completion Date
September 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.
Detailed Description
After experiencing a stroke event, many individuals are left with life-long motor impairments in their upper extremity. However, motor recovery for stroke survivors is not fully understood. One of the challenges to understand the mechanisms behind recovery is the capability of the brain to reorganize and re-activate areas affected by the stroke. Brain computer interface (BCI) has shown promise in previous studies to improve motor capabilities of individuals with damaged nervous systems by reactivating damaged motor pathways.
In order to understand how BCI can be incorporated into upper extremity rehabilitation, investigators must first lay the groundwork of measuring neural activity and its relation to muscle activity in individuals who have experienced a stroke. While instructing participants to open and close their hand, investigators will measure (1) neural activity, called sensorimotor rhythms (SMRs), using a electrophysiological (EEG) cap, and (2) muscle activity using wireless electromyography (EMGs). What the investigators are specifically looking for is an event in the neural activity in between movement initiation and termination called event related desynchronization (ERD). The investigators of this study hypothesize that there is greater activation of ERDs in stroke's subjects SMR activity after completing finger extension and flexion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper Extremity, Body Computer Interface
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Measuring neural activity
Arm Type
Experimental
Arm Description
While completing hand opening/closing, individuals will have the following measured (1) Neural activity (specifically sensorimotor rhythms) using a EEG cap; (2) muscle activity (specifically finger flexors and extensors) using EMG sensors.
Intervention Type
Diagnostic Test
Intervention Name(s)
Event related desynchronization measurement
Intervention Description
Individuals will spend one hour and receive cues to open or close their hand while wearing a EEG cap and EMG sensors on their forearm.
Primary Outcome Measure Information:
Title
Rate of activation of Event Related Desynchronization
Description
Sensorimotor neural activity
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke (6 months post stroke)
Hemiparesis
Some degree of hand and finger movement capability
a moderate impairment (Fugl-Meyer score between 15-50)
Exclusion Criteria:
Individuals under the age of 18
Bilateral paresis
Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)
Botox injection to the affected upper extremity within the previous 4 months
Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24111256
Citation
Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069.
Results Reference
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PubMed Identifier
18258825
Citation
Buch E, Weber C, Cohen LG, Braun C, Dimyan MA, Ard T, Mellinger J, Caria A, Soekadar S, Fourkas A, Birbaumer N. Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke. Stroke. 2008 Mar;39(3):910-7. doi: 10.1161/STROKEAHA.107.505313. Epub 2008 Feb 7.
Results Reference
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PubMed Identifier
17172551
Citation
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Results Reference
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PubMed Identifier
32101735
Citation
Peles O, Werner-Reiss U, Bergman H, Israel Z, Vaadia E. Phase-Specific Microstimulation Differentially Modulates Beta Oscillations and Affects Behavior. Cell Rep. 2020 Feb 25;30(8):2555-2566.e3. doi: 10.1016/j.celrep.2020.02.005.
Results Reference
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PubMed Identifier
24794423
Citation
Triandafilou KM, Kamper DG. Carryover effects of cyclical stretching of the digits on hand function in stroke survivors. Arch Phys Med Rehabil. 2014 Aug;95(8):1571-6. doi: 10.1016/j.apmr.2014.04.008. Epub 2014 May 2.
Results Reference
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PubMed Identifier
27214905
Citation
Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):297-305. doi: 10.1109/TNSRE.2016.2569070. Epub 2016 May 17.
Results Reference
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PubMed Identifier
26529119
Citation
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PubMed Identifier
23494615
Citation
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PubMed Identifier
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Citation
Seo NJ, Rymer WZ, Kamper DG. Delays in grip initiation and termination in persons with stroke: effects of arm support and active muscle stretch exercise. J Neurophysiol. 2009 Jun;101(6):3108-15. doi: 10.1152/jn.91108.2008. Epub 2009 Apr 8.
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Citation
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Citation
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Safety and Feasibility of eGlove
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