Back to resultsAcupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients
Primary Purpose
Stroke, Acute
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrical acupuncture
Acupuncture
tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
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
Sites / Locations
- Pusan national university Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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).
Change of brain activity
The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05648162
First Posted
December 5, 2022
Last Updated
September 19, 2023
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05648162
Brief Title
Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients
Official Title
Convergence of Acupuncture and Transcranial Direct Current Stimulation(tDCS) Rehabilitation Effect on Motor Function of Patients of Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
Arm Type
Experimental
Arm Description
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).
Arm Title
Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Electrical acupuncture
Intervention Description
Electrical acupuncture (2Hz, 150 μs) once daily
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Electrical acupuncture (no electricity) once daily
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
tDCS (1mA) once daily
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
tDCS (no electricity) once daily
Primary Outcome Measure Information:
Title
Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score
Description
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).
Time Frame
Baseline and Week 4
Title
Change of brain activity
Description
The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Change of Korean version of Modified Barthel Index(K-MBI) score
Description
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).
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JISOO BAIK
Phone
+82553604159
Email
zisoo@pusan.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Il Shin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Il Shin, Dr.
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pusan national university Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan
ZIP/Postal Code
50610
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youjin Jeong
Email
ctccrc@pnuyh.co.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients
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