EFFECTIVENESS OF TRIHEXYPHENIDYL FOR TREATMENT OF DYSTONIA IN CHILDREN WITH CEREBRAL PALSY
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Change in score on Global Dystonia Scale
研究概览
简要总结
Effectiveness of Trihexyphenidyl for dystonia in children with Cerebral Palsy
PLACE OF STUDY
The proposed study will be conducted in Department of Pediatrics Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi
STUDY DESIGN
Open-labelled Intervention trial
STUDY POPULATION
Children with Cerebral Palsy with predominant dystonia
Children full filling the inclusion criteria will be included in the study after taking the informed consent and started on the proposed drug protocol and follow up is Done after 3 weeks 6 weeks and final assessment done after 12 weeks ,outcome variables are measured using Global Dystonia Scale,Gross Motor Function Measure 88,Early Developmental Profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Cerebral Palsy diagnosed as per American Academy of Neurology criteria 2006 with : 1.Presence of predominant dystonia 2.Age 6 months to 5 years.
排除标准
- •1.Children who have received Trihexyphenidyl or levodopa in last 3 months.
- •2.Children who have required titration in their Baclofen dosage in last 3 months.
- •3.Poorly controlled epilepsy.
- •4.Diagnosed cases of Glaucoma or Congenital Heart block.
- •5.History of allergy or adverse reaction to anti-cholinergic drugs in the past.
- •6.History of orthopedic surgery or botulinum injection in last 6 months.
结局指标
主要结局
1.Change in score on Global Dystonia Scale
时间窗: Score will be assessed after 12 weeks that is 3months
2.Change in score on Gross Motor Function Measure-88 (GMFM-88)
时间窗: Score will be assessed after 12 weeks that is 3months
3.Change in score on Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2)
时间窗: Score will be assessed after 12 weeks that is 3months
次要结局
- 1.Change in score on Global Dystonia Scale(2.Change in score on Gross Motor Function Measure-88 (GMFM-88))