Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke

Sponsor

Guangzhou University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT03712085

Collaborator

Chinese University of Hong Kong (Other)

Enrollment

Locations

Arms

34.5

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.

Condition or Disease	Intervention/Treatment	Phase
Brain Ischemia Hemiplegic Patients With Stroke Image Science Electrophysiology of Neuromuscular Abdominal Acupuncture	Other: Abdominal acupuncture Other: Sham abdominal acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke

Actual Study Start Date :

Jan 15, 2019

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group A Abdominal acupuncture and upper limb rehabilitation training	Other: Abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.
Sham Comparator: Treatment Group B Sham abdominal acupuncture and upper limb rehabilitation training	Other: Sham abdominal acupuncture Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min. Other Names: Upper limb rehabilitation training
No Intervention: Control Group Upper limb rehabilitation only

Arm

Intervention/Treatment

Active Comparator: Treatment Group A

Abdominal acupuncture and upper limb rehabilitation training

Other: Abdominal acupuncture

Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.

Sham Comparator: Treatment Group B

Sham abdominal acupuncture and upper limb rehabilitation training

Other: Sham abdominal acupuncture

Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min.

Other Names:

Upper limb rehabilitation training

No Intervention: Control Group

Upper limb rehabilitation only

Outcome Measures

Primary Outcome Measures

The integrity of the corticospinal tract [Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.]
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Motor function of muscles [SEMG will be tested before and after 4 weeks treatment,twice totally.]
Common measures of sEMG will be tested. See the study protocol for details.

Secondary Outcome Measures

Wolf Motor Function Test [Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.]
See the study protocol for details
Brunnstrom staging of upper limb movement [Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.]
See the study protocol for details
Fugl-Meyer Motor Assessment of upper limb [Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.]
See the study protocol for details
Modified Barthel Index，MBI [Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.]
See the study protocol for details

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
Age 35 to 75 years old;
Course of disease 0.5 to 3 months with stable vital signs;
No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
Agree to sign the informed consent;
Unilateral neglect.

Exclusion Criteria:

Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
Contraindication to undergo a 3T MR imaging;
Claustrophobia;
Have severe heart, hepatic or renal failure;
Don' t cooperate with the treatment;
Have participated in other clinical trails recently.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	China	510120
2	The Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine
Chinese University of Hong Kong

Investigators

Principal Investigator: Hongxia Chen, Master, Director of the rehabilitation department
Principal Investigator: Vincet Chi-kwan Cheung, Doctor, Assistant professor