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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Active Comparator | Abdominal acupuncture and upper limb rehabilitation training |
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| Treatment Group B | Sham Comparator | Sham abdominal acupuncture and upper limb rehabilitation training |
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| Control Group | No Intervention | Upper limb rehabilitation only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal acupuncture | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxia Chen, Master | Contact | 020-39318381 | +8613609031028 | chx2004@126.com |
| Ruihuan Pan, Doctor | Contact | 020-39318381 | +8613763334058 | panruihuan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongxia Chen, Master | Director of the rehabilitation department | Principal Investigator |
| Vincet Chi-kwan Cheung, Doctor | Assistant professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2017 | Jul 7, 2018 |
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| Sham abdominal acupuncture | 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. |
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| 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. |
| The Chinese University of Hong Kong | Not yet recruiting | Hong Kong | Hong Kong |
|
| ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2017 | Jul 7, 2018 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 15, 2017 | Jul 7, 2018 | Prot_002.pdf |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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