Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
研究概览
简要总结
The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient
详细描述
This study is a prospective and double-blinded randomized control trial. Thirty-two stroke patients with spastic equinus were randomly assigned to receive three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait speed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged greater than 18 years old;
- •at least 6 months since onset of last stroke;
- •triceps surae muscle tone graded at least 1+ on the Modified Ashworth Scale (MAS) score;
- •ability to walk alone with/without orthosis.
排除标准
- •Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg
研究组 & 干预措施
radial shock wave
Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz.The intensities of RSWT were 2.0 bar.
干预措施: Radial shock wave (Device)
focused shock wave
Treatment was administered directly to the middle of muscle bellies of the spastic triceps surae muscle in three sessions, with one week interval. During each session, 3000 pulses (1500 shots in the gastrocnemius and 1500 shots in the soleus muscle) were delivered at 5 Hz. The intensities of FSWT were 0.10 mJ/mm2.
干预措施: Focused shock wave (Device)
结局指标
主要结局
Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
时间窗: 1, 4, 8 week
Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
次要结局
- Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.(1, 4, 8 week)
- Change from baseline of gait speed on 8th weeks after treatment.(8 week)
研究者
Gwo-Chi Hu,PHD
PHD
Mackay Memorial Hospital