Safety and Feasibility of eGlove

Shirley Ryan AbilityLab

Status: Completed

Conditions: Stroke

Treatments: Diagnostic Test: Event related desynchronization measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05345301

STU00216276

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Measuring neural activity

Experimental group

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.

Treatment:

Diagnostic Test: Event related desynchronization measurement