Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Electrical acupuncture; Device: tDCS; Other: NDT-Bobath Rehabilitation; Device: Acupuncture; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan
    • Gyeongsang, Yangsan, Korea, Republic of, 50610
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation; 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; Electrical acupuncture (2Hz, 150 μs) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.; Device: tDCS; tDCS (1mA) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.; Other: NDT-Bobath Rehabilitation; NDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.
Active Comparator: Acupuncture + sham tDCS + NDT-Bobath Rehabilitation; 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).	Other: NDT-Bobath Rehabilitation; NDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.; Device: Acupuncture; Electrical acupuncture (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.; Device: sham tDCS; tDCS (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Study Director: Young-Il Shin, Dr., Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 03-2022-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No