Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
试验速览
- 阶段
- 不适用
- 入组人数
- 1,208
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Modified Ashworth Scale
时间窗: 6 months
the common used clinical measurement to assess the levels of limb spasticity
次要结局
- Fugl-Meyer Moter Assessment(6 months)
研究者
JiangFeng
JiangFeng Clinical Professor
The First Affiliated Hospital with Nanjing Medical University