Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to confirm the convergence effectiveness of on acupuncture of the chinese medicine and the tDCS of the western medicine on motor function for patients with acute stroke compared to the control group.

Official Title
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Convergence of Acupuncture and Transcranial Direct Current Stimulation(tDCS) Rehabilitation Effect on Motor Function of Patients of Acute Stroke

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Electrical acupuncture
* Device: Acupuncture
* Device: tDCS
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who within 2 weeks or more and 6 months after a stroke diagnosis. Those who have a lesion with a cortex or subcortex Adults over 19 years old Inpatients and outpatients who can mediate for 4 weeks Those who can understand and follow the purpose of this study Exclusion Criteria: Those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tDCS Those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tDCS Those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia A person who judges that it is not appropriate for a researcher to participate in this study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation<br>Electrical acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times). | Device: Electrical acupuncture<br>* Electrical acupuncture (2Hz, 150 μs) once daily<br>Device: tDCS<br>* tDCS (1mA) once daily<br>|
| Active Comparator: Acupuncture + sham tDCS + NDT-Bobath Rehabilitation<br>Acupuncture, tDCS, and NDT-BOBATH rehabilitation were performed for 30 minutes per time, respectively. The number of intervention was held for about a month, five times a week(a total of 20 times). | Device: Acupuncture<br>* Electrical acupuncture (no electricity) once daily<br>Device: sham tDCS<br>* tDCS (no electricity) once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score | The FMA is a validated, instrument assessing average motor function of upper and lower extremity. Possible scores range from 0(worst motor function) to 212(best motor function). Change= (Week 4 Score - Baseline Score). | Baseline and Week 4 | 
| Change of brain activity | The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score). | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Korean version of Modified Barthel Index(K-MBI) score | The MBI is a validated, instrument assessing average level of ADL(activity of daily living). Possible scores range from 0(maximal independence) to 100(minimal independence). Change= (Week 4 Score - Baseline Score). | Baseline and Week 4 |