Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the therapeutic effect of acupuncture method of Xing Nao Kai Qiao for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.

Detailed Description
-----------------
This study is a multi-center randomized controlled trial comparing three treatment groups.The trial is completed in the following three hospitals: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) of China, Tianjin Hospital of TCM of China, and Qingdao Haici Medical group of Shangdong province of China. The total observation period within this study is 24 weeks for each patient. All patients should remain hemiplegia within 15～90 days after stroke. After randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. The outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. 288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.The patients in the three groups are blinded as to which treatment method they received. The central randomization is used in this trial, which is performed by the Drug Clinical Research Center of Shanghai University of TCM of China. This trial is performed according to the principles of the Declaration of Helsinki (Version Edinburgh 2000). And the trial protocol has been approved by local institutional review board and ethics committee.

Official Title
-----------------
Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Other: acupuncture
* Behavioral: rehabilitation
* Other: acupuncture and rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral infarction diagnosed according to the diagnostic standard of western medicine Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI The incidence of apoplexy less than twice and the time of onset 15 3 months Age: 40-75 years, non-limited gender NDS score of limb functional defect ≥10 The patient was alert and the vital signs are stable Participant signed the informed consent form Exclusion Criteria: TIA or RIND The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease Pregnant or breast-feeding women Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br> | Other: acupuncture<br>* Xing Nao Kai Qiao Acupuncture<br>|
| Active Comparator: rehabilitation<br> | Behavioral: rehabilitation<br>* Kinesitherapy<br>|
| Active Comparator: acupuncture and rehabilitation<br> | Other: acupuncture and rehabilitation<br>* Xing Nao Kai Qiao Acupuncture plus Kinesitherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of neurological defect |  | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualized anologue score |  | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. | 
| Spasm evaluation |  | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. | 
| Safety evaluation |  | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral infarction, Paralysis, acupuncture, rehabilitation, trial