Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength

National Rehabilitation Center, Seoul, Korea1 site in 1 country30 target enrollmentJuly 1, 2020

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: National Rehabilitation Center, Seoul, Korea
Enrollment: 30
Locations: 1
Primary Endpoint: Fugl-Meyer Assessment - upper extremity
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

Detailed Description

The purpose of this study is to compare RecoveriX with individual EEG calibration and without individual EEG calibration to determine the clinical effect of brain machine interface in chronic stroke patient without wrist extensor strength

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Rehabilitation Center, Seoul, Korea

Responsible Party

Principal Investigator

Joon-Ho Shin

Chief of Brain Injury Rehabilitation Department, Principal Investigator

National Rehabilitation Center, Seoul, Korea

Eligibility Criteria

Inclusion Criteria

•Hemiplegic patients secondary to first cerebrovascular accidents
•Weak wrist extension
•Onset ≥ 6 months
•Fugl-Meyer Assessment score ≥ 19
•Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria

•Wrist extensor spasticity above or modified ashworth scale 2
•Severe upper extremity pain that could interfere with rehabilitation therapy
•Neurological disorders other than stroke that can cause motor deficits
•Uncontrolled severe medical conditions.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment - upper extremity

Time Frame: 4 weeks after baseline

Fugl-Meyer Assessment is indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment. Total scores range from 0 to 66, each item being scored on a 3-point scale (0, cannot perform; 1, partially performs; and 2, fully performs the task).

Secondary Outcomes

Box and block test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Jebsen hand function test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
9-hole peg test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Medical Research Council (MRC) scale of affected upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Sensation of limb movement(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Modified Ashworth scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Joint position sense(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
active range of motion (AROM) of wrist flexion/extension(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Motor evoked potential(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Stroke impact scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
electroencephalography (EEG) effective connectivity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Stroke rehabilitation motivation scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
Intrinsic motivation inventory(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)