Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

Not Applicable

Completed

• Conditions: Stroke, Acute
• Interventions: Device: Acupuncture; Device: Electrical acupuncture; Device: sham tDCS; Device: tDCS; Other: NDT-Bobath Rehabilitation

• Registration Number: NCT05648162
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-05
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture + sham tDCS + NDT-Bobath Rehabilitation	Acupuncture	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 + sham tDCS + NDT-Bobath Rehabilitation	sham tDCS	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).
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation	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).
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation	Electrical acupuncture	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).
Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation	tDCS	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 + sham tDCS + NDT-Bobath Rehabilitation	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).

Primary Outcome Measures

Name	Time	Method
Change of brain activity	Baseline and Week 4	The fNIRS(functional Near-Infrared Spectroscopy) is a imaged, instrument assessing average brain activity. Change= (Week 4 Score - Baseline Score).
Change of Korean version of the Fugl-Meyer Assessment Scale(K-FMA) score	Baseline and Week 4	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).

Secondary Outcome Measures

Name	Time	Method
Change of Korean version of Modified Barthel Index(K-MBI) score	Baseline and Week 4	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).

Trial Locations

Locations (1)

Pusan national university Yangsan Hospital; 🇰🇷 Gyeongsang, Yangsan, Korea, Republic of