Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Tardieu scale
研究概览
简要总结
Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis.
Method: this study will assess the effectiveness of radial SWT to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (< 12 months) with chronic patients presenting muscle contractures (> 12 months). Forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. One real and one sham sessions of SWT will be performed with a 2-week interval. The order of the sessions will be randomized. Motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. The targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •History of cerebral lesion
- •Wrist spasticity ≥ 1+/4 on the Modified Ashworth Scale
- •Wrist spasticity ≥ 2/4 on the Tardieu Scale
- •Passive dorsal extension of the wrist ≥ 10°
排除标准
- •Botulinum toxin injection in the upper limb in the past three months
- •History of wrist arthrodesis
- •Treatment with oral anticoagulants or coagulation disease
- •Tumor or infection of the paretic upper limb
结局指标
主要结局
Tardieu scale
时间窗: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)
Modified Ashworth Scale
时间窗: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)
次要结局
- objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad(Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Isokinetic dynamometer(Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Medical Research Council muscle testing(Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Box and block test(Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Visual Analog Scale(Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- objective measure of muscle stiffness(Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- manual goniometer(Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- H reflex(Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Fugl Meyer Assessment - computerized adaptive testing(Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Wolff Motor Function Test(Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT))
- Abilhand scale(Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT))