COMPARATIVE CLINICAL ASSESSMENT OF VARIOUS THERAPEUTIC MODALITIES IN THE MANAGEMENT OF SPASTICITY IN CHILDREN WITH CEREBRAL PALSY
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Compare the effectiveness of various treatment modalities in the management of spasticity in children with Cerebral Palsy
研究概览
简要总结
The aim of the study is to evaluate and compare the effectiveness of various treatment modalities in the management of Spasticity in children with Cerebral Palsy. Patients who are fulfilling the criteria for diagnosis and inclusion will be selected for the study. The primary purpose is to compare the effectiveness of various treatment modalities in the management of spasticity in children with Cerebral Palsy while the end point is to appreciate the efficacy of therapy and patient well being. The clinical study will be single centered, open labelled, four arm prospective clinical trial, planned to be conducted in tertiary care teaching hospital attached to Ayurveda Medical college located in district head quarters. The study will be carried out and completed in 2 years duration. 80 patients will be selected successively from the out patient department of Kaumarabhritya of the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 3-8 years of both gender 2) Children whose parents are willing to sign the informed assent form 3) If participant history of epilepsy,well controlled by medication.
排除标准
- •Mixedvariety of cerebral palsy.
- •Children with infectious diseases like tuberculosis, meningitis 3)Children with poor controlled epilepsy,recurrent status epilepticus, intractable seizures, complex seizures, juvenile diabetes mellitus,severe cognitive impairment.
- •With Severe motor handicap and deformities from long standing spasticity.
- •The children of cerebral palsy with congenital malformations, other systemic illness like congenital heart disease, nephrotic syndrome will be excluded from the study.
结局指标
主要结局
Compare the effectiveness of various treatment modalities in the management of spasticity in children with Cerebral Palsy
时间窗: 180 days
次要结局
- Efficacy of therapy and patient well being(180 days)