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

Study Overview
=================
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.

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

Conditions
-----------------
Brain Ischemia, Hemiplegic Patients With Stroke, Image Science, Electrophysiology of Neuromuscular, Abdominal Acupuncture

Intervention / Treatment
-----------------
* Other: Abdominal acupuncture
* Other: Sham abdominal acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group A<br>Abdominal acupuncture and upper limb rehabilitation training | Other: Abdominal acupuncture<br>* 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.<br>|
| Sham Comparator: Treatment Group B<br>Sham abdominal acupuncture and upper limb rehabilitation training | Other: Sham abdominal acupuncture<br>* 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.<br>* Other names: Upper limb rehabilitation training;|
| No Intervention: Control Group<br>Upper limb rehabilitation only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The integrity of the corticospinal tract | 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. | Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally. | 
| Motor function of muscles | Common measures of sEMG will be tested. See the study protocol for details. | SEMG will be tested before and after 4 weeks treatment,twice totally. | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional magnetic resonance imaging（fMRI）, Surface electromyography （sEMG）, Abdominal acupuncture, Brain Plasticity, Effects and mechanism