Radial Shockwave Therapy With ShockMaster 300® to Reduce Spasticity in Children With CP or Acquired Brain Injury: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
The goal of this clinical trial is to determine if radial Extracorporeal shockwave therapy (rESWT) reduces spasticity in children with Cerbral Palsy (CP) or traumatic brain injury (TBI). The main questions it aims to answer are:
- Is it feasible to implement radial shockwave therapy in conventional physiotherapy plan in children with CP or TBI?
- Is it safe and effective to use rESWT for reducing spasticity in children with CP or TBI? Participants will receive a 4 week therapy intervention, as add on to the conventional physio (usual care), including one rESWT session per week for a total of 4 sessions.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cerebral palsy or acquired brain injury
- •between 6-18 years old;
- •gross motor function classification ≥2;
- •experiencing spasticity in the lower limb (calf muscles, hip adductor muscles or hamstring muscles) and/or in the upper limb (biceps muscle, wrist flexor muscles, finger flexor muscles) with Modified Ashworth Scores (MAS) ≥1+.
排除标准
- •recent (≤3 months) Botox injections or other recent (≤6 months) invasive intervention;
- •local infections or wounds; neuropathy;
- •severe organ dysfunction;
- •severe psychosocial dysfunction that would not allow adhering to protocol;
- •planned changes in medication dosage or medication scheme that might affect spasticity during a 4-month intervention and follow-up phase.
研究组 & 干预措施
Usual care
Conventional physiotherapy plan
干预措施: Conventional treatment (Other)
Shockwave and usual care
All participants receive a 4-week rESWT intervention plan (4 sessions with a one week interval), as add-on to the conventional physiotherapy plan
干预措施: radial Extracorporeal shockwave therapy (rESWT) (Device)
Shockwave and usual care
All participants receive a 4-week rESWT intervention plan (4 sessions with a one week interval), as add-on to the conventional physiotherapy plan
干预措施: Conventional treatment (Other)
结局指标
主要结局
Modified Ashworth Scale
时间窗: Change from baseline to 3 months follow-up
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion. The scale is validated for use in various clinical populations to measure spasticity. The MAS score varies form 0 (no increase in tone) up to 4 (limb rigid in flexion or extension).
Modified Ashworth Scale
时间窗: Change from baseline to the end of intervention sessions at week 4
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion. The scale is validated for use in various clinical populations to measure spasticity. The MAS score varies form 0 (no increase in tone) up to 4 (limb rigid in flexion or extension).
次要结局
- Patient Specific Functional Scale(Change from baseline to 3 months follow-up)
- passive Range Of Motion(Change from baseline to 3 months follow-up)
- Patient Specific Functional Scale(Change from baseline to the end of intervention sessions at week 4)
- passive Range Of Motion(Change from baseline to the end of intervention sessions at week 4)