Clinical Effects of Brain Machine Interface in Chronic Stroke Patient
- Conditions
- Stroke
- Interventions
- Device: RecoveriX without individual EEG calibration
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Arm && Interventions
Group Intervention Description RecoveriX without individual EEG calibration RecoveriX without individual EEG calibration RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks
- 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