TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

Detailed Description
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A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Official Title
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Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity

Conditions
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Stroke

Intervention / Treatment
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* Other: Modern rehabilitation treatment
* Other: Modern rehabilitation &TCM
* Other: modern rehabilitation &Baimai Ruangao
* Other: modern rehabilitation &Tibetan medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to the diagnostic criteria of stroke and diagnosed by CT or MRI Patient must be between the ages of 18 and 85 years. All patients were examined at least 1 month after stroke and less than 12 months. At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale) Body movement function decreased significantly. The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used Patient must understand and be willing, able and likely to comply with all study procedures. Patient must be able to give voluntary written informed consent. Exclusion Criteria: Significant cognitive defects(MMSE<16)，unable to finish the Fugl-Meyer scale,etc.. Other significant limb diseases such as fracture, severe arthritis,amputation Joint contracture formation Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment Patients need nerve block at any point of time during the whole experiment procedure. Serious cardiac,hepatic or renal insufficiency and patients with shock. Limb skin of patients who need medicated is visible wound. Patients with cancer or pregnancy Patients who participate in other clinical studies within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modern rehabilitation treatment<br>Modern rehabilitation treatment | Other: Modern rehabilitation treatment<br>* PT 1 hour per day and OT 30min per day<br>|
| Experimental: Modern rehabilitation &TCM<br>Modern rehabilitation treatment and traditional Chinese medicine | Other: Modern rehabilitation &TCM<br>* Traditional Chinese Medicine, including massage and medicated bath<br>|
| Experimental: modern rehabilitation &Baimai Ruangao<br>modern rehabilitation treatment and Baimai Ruangao | Other: modern rehabilitation &Baimai Ruangao<br>* modern rehabilitation treatment with Baimai Ruangao and massage<br>|
| Experimental: modern rehabilitation &Tibetan medicine<br>modern rehabilitation treatment and Tibetan medicine treatment | Other: modern rehabilitation &Tibetan medicine<br>* modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | the common used clinical measurement to assess the levels of limb spasticity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Moter Assessment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Traditional Chinese Medicine, Rehabilitation