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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

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ClinicalTrials.gov Identifier: NCT03712085
Recruitment Status : Unknown
Verified July 2019 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 19, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Upper limb rehabilitation training
No Intervention: Control Group
Upper limb rehabilitation only


Outcome Measures
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Primary Outcome Measures :
  1. The integrity of the corticospinal tract [ Time Frame: 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.

  2. Motor function of muscles [ Time Frame: 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 :
  1. Wolf Motor Function Test [ Time Frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally. ]
    See the study protocol for details

  2. Brunnstrom staging of upper limb movement [ Time Frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally. ]
    See the study protocol for details

  3. Fugl-Meyer Motor Assessment of upper limb [ Time Frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally. ]
    See the study protocol for details

  4. Modified Barthel Index，MBI [ Time Frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally. ]
    See the study protocol for details


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712085


Contacts
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Contact: Hongxia Chen, Master 020-39318381 ext +8613609031028 chx2004@126.com
Contact: Ruihuan Pan, Doctor 020-39318381 ext +8613763334058 panruihuan@163.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Hongxia P Chen, Master    020-81887233 ext 02039318381    chx2004@126.com   
Contact: Ruihuan P Pan, Doctor    020-81887233 ext 02081887233    panruihuan@163.com   
Principal Investigator: Hongxia P Chen, Master         
Sub-Investigator: Vincet Chi-kwan P Cheung, Doctor         
Sub-Investigator: Ruihuan P Pan, Doctor         
Sub-Investigator: Bo Liu, Master         
Sub-Investigator: Youhua Guo, Master         
Sub-Investigator: Zhijing Yang, Master         
Sub-Investigator: Lechang Zhan, Master         
Sub-Investigator: Mingfeng He, Master         
Sub-Investigator: Chunxing Duan, Master         
Sub-Investigator: Shanshan Ling, Postgraduate         
Hong Kong
The Chinese University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Vincent Chi-Kwan Cheung, Doctor    (852)59270597    vckc@cuhk.edu.cn   
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Chinese University of Hong Kong
Investigators
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Principal Investigator: Hongxia Chen, Master Director of the rehabilitation department
Principal Investigator: Vincet Chi-kwan Cheung, Doctor Assistant professor
  Study Documents (Full-Text)

Documents provided by Guangzhou University of Traditional Chinese Medicine:
Informed Consent Form  [PDF] September 15, 2017
Statistical Analysis Plan  [PDF] September 15, 2017
Study Protocol  [PDF] September 15, 2017

More Information
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Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03712085    
Other Study ID Numbers: YN2018HK03
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Functional magnetic resonance imaging（fMRI）
Surface electromyography （sEMG）
Abdominal acupuncture
Brain Plasticity
Effects and mechanism
Additional relevant MeSH terms:
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Stroke
Brain Ischemia
Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes