The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Modified ashworth scale of upper extremities spasticity
研究概览
简要总结
There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.
详细描述
If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 6 weeks after stroke diagnosis
- •upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2
- •ability to stand and walk safely without help or assistance
排除标准
- •improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- •previous contracture and/or deformity of the upper extremities
- •concurrent peripheral neuropathy and/or myopathy
- •difficulty in participating in the study due to cognitive impairment.
结局指标
主要结局
Modified ashworth scale of upper extremities spasticity
时间窗: Three months after treatment
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
次要结局
- Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity(Pre-treatment (baseline))
- Modified barthel index(Three months after treatment)
- Modified tardieu scale of upper extremities spasticity(Three months after treatment)
- Fugl-Meyer assessment of upper extremity(Three months after treatment)
- Action research arm test(Three months after treatment)