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OpenTrials
Completed

NCT Number: NCT05345301

Safety and Feasibility of eGlove

The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Event related desynchronization measurement

Diagnostic Test

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 outcomes

  1. Rate of activation of Event Related Desynchronization

    Time frame: 1 hour

    Sensorimotor neural activity

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Electroencephalographic Correlates of Glove-stretch Therapy Post-stroke

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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