Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Changes in spasticity
研究概览
简要总结
Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions.
This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First hemiplegic ischemic stroke.
- •Chronic stroke (stroke at least 6 months before the trial).
- •Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
- •Preserve cognitive capacity.
- •Being able to understand and follow simple instructions.
- •Not afraid of needles.
排除标准
- •Recurrent stroke.
- •Subjects with cognitive disorders.
- •Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
- •Alteration of sensitivity.
- •Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
- •Hemorrhagic stroke.
- •Subjects who do not consent to participate in the study.
结局指标
主要结局
Changes in spasticity
时间窗: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement. The scale goes from 0 to 4 points. The higher the score, the greater the impact. Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
次要结局
- Changes in range of motion(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Gait(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Motor function of the upper and lower limb(Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.)
- Changes in Physical disability(Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.)
研究者
Rocío Martín Valero
PhD
University of Malaga