Prospective double blind RCT comparing radial Extracorporeal Shockwave therapy (rESWT) vs placebo in treatment of calf spasticity in children with cerebral palsy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Calibrated passive range of motion of the ankle
研究概览
简要总结
Cerebral palsy (CP) isone of the leading causes of movement and posture disorders. Cerebral palsy ischaracterised by spasticity, decreased selective motor control and progressivejoint contractures. Calf spasticity is one of the common clinical featureswhich results in ankle equinus and decreased range of ankle dorsiflexion, whichif untreated, subsequently results in equinus contracture. rESWT is a newmodality of treatment for spasticity, In this study we will be comparing theefficacy of rESWT in improving the ROM at the ankle as well as decreasing calfspasticity.
Children withCP under the age of 7 will be screened in the Paediatric Orthopaedicout-patient department (OPD) and will be randomised to an intervention groupand a control group, 45 in each group. The intervention group will receiverESWT and the control group will receive sham rESWT. Both groups will receive astandardised regime of Oral baclofen and physiotherapy. rEWST will be given in2 sittings , 3 days apart. The childrenwill be followed up at 6 weeks and 3 months.
The primaryoutcome measure which is improvement in ankle dorsiflexion range will bemeasured by using standardised clinical photographs and improvement inspasticity by Modified Ashworth Score. At final followup, patient / parentsatisfaction will be evaluated on a 5 point likert scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 7.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with CP under 7 years of age with calf spasticity, MAS of 2 or more.
排除标准
- •Previous surgery to calf Botox injection to the calf Inability to comply with followup Bleeding disorders/blood dyscrasias/ seizure disorder.
结局指标
主要结局
Calibrated passive range of motion of the ankle
时间窗: Immediate procedure | 6 weeks | 3 months
次要结局
- Modified Ashworth Scale (MAS)(Parent reported satisfaction on likert scale)
