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

NCT ID: NCT03712085

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-12-31

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.

Conditions

Brain Ischemia; Hemiplegic Patients With Stroke; Image Science; Electrophysiology of Neuromuscular; Abdominal Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group A

Abdominal acupuncture and upper limb rehabilitation training

Group Type: ACTIVE_COMPARATOR

Abdominal acupuncture

Intervention Type: OTHER

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.

Treatment Group B

Sham abdominal acupuncture and upper limb rehabilitation training

Group Type: SHAM_COMPARATOR

Sham abdominal acupuncture

Intervention Type: OTHER

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.

Control Group

Upper limb rehabilitation only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Upper limb rehabilitation training

Eligibility Criteria

Inclusion Criteria

1. First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;

2. Age 35 to 75 years old;

3. Course of disease 0.5 to 3 months with stable vital signs;

4. No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;

5. 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;

6. Agree to sign the informed consent;

7. Unilateral neglect.

Exclusion Criteria

1. Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;

2. Contraindication to undergo a 3T MR imaging;

3. Claustrophobia;

4. Have severe heart, hepatic or renal failure;

5. Don' t cooperate with the treatment;

6. Have participated in other clinical trails recently.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxia Chen, Master

Role: PRINCIPAL_INVESTIGATOR

Director of the rehabilitation department

Vincet Chi-kwan Cheung, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Locations

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: NOT_YET_RECRUITING

Countries

China; Hong Kong

Central Contacts

Hongxia Chen, Master

Role: CONTACT

chx2004@126.com

020-39318381 ext. +8613609031028

Ruihuan Pan, Doctor

Role: CONTACT

panruihuan@163.com

020-39318381 ext. +8613763334058

Facility Contacts

Hongxia P Chen, Master

Role: primary

chx2004@126.com

020-81887233 ext. 02039318381

Ruihuan P Pan, Doctor

Role: backup

panruihuan@163.com

020-81887233 ext. 02081887233

Vincent Chi-Kwan Cheung, Doctor

Role: primary

vckc@cuhk.edu.cn

(852)59270597

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

YN2018HK03

Identifier Type: -

Identifier Source: org_study_id