Clinical trial NCT05345301: Safety and Feasibility of eGlove
Official title: Electroencephalographic Correlates of Glove-stretch Therapy Post-stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Upper Extremity
Body Computer Interface
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Rate of activation of Event Related Desynchronization
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References:
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