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临床试验/CTRI/2019/06/019666
CTRI/2019/06/019666尚未招募3 期

Prospective double blind RCT comparing radial Extracorporeal Shockwave therapy (rESWT) vs placebo in treatment of calf spasticity in children with cerebral palsy

Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年6月17日最近更新:

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)

研究者

发起方
Christian Medical College Vellore
申办方类型
Private medical college

研究点 (1)

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