NCT05648162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

December 5, 2022

Last Update Submit

May 16, 2024

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change of Korean version of Modified Barthel Index(K-MBI) score

    Baseline and Week 4

Study Arms (2)

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

EXPERIMENTAL

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 acupunctureDevice: tDCSOther: NDT-Bobath Rehabilitation

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation

ACTIVE COMPARATOR

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: AcupunctureDevice: sham tDCSOther: NDT-Bobath Rehabilitation

Interventions

Electrical acupunctureDEVICE

Electrical acupuncture (2Hz, 150 μs) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
AcupunctureDEVICE

Electrical acupuncture (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
tDCSDEVICE

tDCS (1mA) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

Electrical acupuncture+ tDCS + NDT-Bobath Rehabilitation
sham tDCSDEVICE

tDCS (no electricity) once daily (five times a week), for 20 minutes each session, totaling 20 sessions.

Acupuncture + sham tDCS + NDT-Bobath Rehabilitation
NDT-Bobath RehabilitationOTHER

NDT-Bobath Rehabilitation once daily (five times a week), for 30 minutes each session, totaling 20 sessions.

Acupuncture + sham tDCS + NDT-Bobath RehabilitationElectrical acupuncture+ tDCS + NDT-Bobath Rehabilitation

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture TherapyTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsElectric Stimulation TherapyConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Young-Il Shin, Dr.

    Pusan National University Yangsan Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

July 5, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)