Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.
Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.
详细描述
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.
Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.
Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.
This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old
- •Time from stroke (ischemic o hemorrhagic) onset of at least 6 months
- •Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score
- •Ability to walk alone with or without aids
排除标准
- •Fixed ankle joint contracture
- •Severe medical problems
- •Treatment of the affected leg with botulinum toxin in the las 6 months
- •Cognitive impairment
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome
次要结局
- Visual Analogue Scale (VAS) Pain Score(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Test Up and Go (TUG)(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Spasm Frequency Scale(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Fall Skip Device(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Stroke Quality of Life Scale (ECVI-38)(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Passive Ankle range of motion (PROM)(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- 10 Meters Walk Test(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Test 6 Minutes Walking(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
- Self Report Spasticity Scale (SRSS)(Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.)
研究者
Teresa Mateu Campos
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana