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Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT05345301
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
9.1
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Event related desynchronization measurement
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Electroencephalographic Correlates of Glove-stretch Therapy Post-stroke
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Measuring neural activity

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.

Diagnostic Test: Event related desynchronization measurement
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.

Outcome Measures

Primary Outcome Measures

  1. Rate of activation of Event Related Desynchronization [1 hour]

    Sensorimotor neural activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Patton, Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05345301
Other Study ID Numbers:
  • STU00216276
First Posted:
Apr 25, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by James Patton, Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab
Upper Extremity
Body Computer Interface
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of May 2, 2022