Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

Not Applicable

• Conditions: Stroke

• Registration Number: NCT04451941
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

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

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Status Verified: 2020-07
• Study Start: 2020-07-01
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment - upper extremity	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 Outcome Measures

Name	Time	Method
Box and block test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.
Jebsen hand function test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Jebsen hand function test provides a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living. Total score is the sum of time taken for each subtest, which are rounded to the nearest second. Shorter times indicate better performance.
9-hole peg test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	9-hole peg test measures finger dexterity in patients with stroke. Scores are based on the time taken to complete the test activity, recorded in seconds.
Medical Research Council (MRC) scale of affected upper extremity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	The MRC is a standardized set of assessments that measure muscle strength and function.; The MRC scale of muscle strength uses a score of 0 to 5 to grade the power of a particular muscle group in relation to the movement of a single joint.
Sensation of limb movement	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	For the ability to sense a sharp object, the best screening test uses a safety pin or other sharp object to lightly prick the face, torso, and 4 limbs; the patient is asked whether the pinprick feels the same on both sides and whether the sensation is dull or sharp.
Modified Ashworth scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Modified Ashworth scale measures resistance during passive soft-tissue stretching.; Scores range from 0-4, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity.
Joint position sense	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Joint position sense is tested by holding the most distal joint of a digit by its sides and moving it slightly up or down. First, demonstrate the test with the patient watching so they understand what is wanted then perform the test with their eyes closed.
active range of motion (AROM) of wrist flexion/extension	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	active range of motion of wrist flexion and extension
Motor evoked potential	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	action potential elicited by noninvasive stimulation of the motor cortex through the scalp
Stroke impact scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Stroke impact scale evaluates how stroke has impacted your health and life. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100.
electroencephalography (EEG) effective connectivity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	EEG effective connectivity describes the causal influences that neural units exert over another.
Stroke rehabilitation motivation scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Stroke rehabilitation motivation scale includes 28 items applicable to stroke rehabilitation, adapted from the Sports Motivation Scale. The response to each item is measured on a scale of 1 to 5. Higher score indicates higher rehabilitation motivation level for all items, except three reverse evaluation items (items #5, #12, and #23), for which a higher score indicates lower motivation level.
Intrinsic motivation inventory	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	The Intrinsic Motivation Inventory assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity, thus yielding six subscale scores. A higher score will indicate more of the concept described in the subscale name.

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of