Clinical trial NCT04451941: Clinical Effects of Brain Machine Interface in Chronic Stroke Patient
Official title: Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: brain machine interface
chronic stroke
wrist extensor strength
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2020-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Fugl-Meyer Assessment - upper extremity
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Box and block test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Jebsen hand function test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: 9-hole peg test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Medical Research Council (MRC) scale of affected upper extremity
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Joint position sense
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Sensation of limb movement
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: active range of motion (AROM) of wrist flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Modified Ashworth scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke impact scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: electroencephalography (EEG) effective connectivity
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke rehabilitation motivation scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Intrinsic motivation inventory
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Motor evoked potential
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin
role: PRINCIPAL_INVESTIGATOR
References: