Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.
This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Changhua
-
Taiwan、Changhua、台湾、500
- Changhua Christian Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- first-ever stroke, with spasticity within 3-months (MAS=2~3)
- independent walking 10 meters (with assistive devices)
Exclusion Criteria:
- recurrent stroke, cognition impaired
- lower limb fracture
- received anti-spasticity injection in the past
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Botox_A
receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
|
|
|
安慰剂比较：placebo_A
receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month.
|
|
|
实验性的：Botox_B
receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.
|
|
|
安慰剂比较：placebo_B
receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the muscle tone in upper and lower extremity
大体时间：4 weeks after injection
|
use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal
|
4 weeks after injection
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in the gait pattern as walking
大体时间：4 weeks after intervention
|
4 weeks after intervention
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.