TRIHEXYPHENIDYL FOR TREATMENT OF DYSTONIA IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED PLACEBO CONTROLLED TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- OUTCOME VARIABLES
研究概览
简要总结
Children aged 6 months to 5 years attending Child Developmental center, Department of pediatrics, on 2 predesignated days would be evaluated for Dyskinetic cerebral palsy. Those fulfilling inclusion/exclusion criteria will be recruited. Baseline evaluation using Global Dystonia Scale, Gross motor function measure 88, Early Developmental profile 2 will be done. Following which the enrolled children will be randomised into intervention arm and control arm. The subjects would be started on trihexyphenidyl in the intervention arm and placebo in the control arm for 12 weeks. Occupational and physical therapy will also be given to both the arms. Follow up would be done at 3rd weeks, 6th weeks and final assessment at 12 week where all scales will be readministered. Statistical analysis will be done using unpaired test to compare continues variables and fischer exact test for catogorical variable at baseline and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Residents of Delhi NCR.
排除标准
- •1.Children who have received Trihexyphenidyl, any other anti-cholinergic 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.
- •7.Presence of features of contractures or hip dislocation.
结局指标
主要结局
OUTCOME VARIABLES
时间窗: Follow Up would be done at 3 weeks and 6 weeks and final assessment would be done after 12 weeks during which all the scales would be re administered.
Change in score on Global Dystonia Scale.
时间窗: Follow Up would be done at 3 weeks and 6 weeks and final assessment would be done after 12 weeks during which all the scales would be re administered.
Change in score on Gross Motor Function Measure-88 (GMFM-88).
时间窗: Follow Up would be done at 3 weeks and 6 weeks and final assessment would be done after 12 weeks during which all the scales would be re administered.
Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2).
时间窗: Follow Up would be done at 3 weeks and 6 weeks and final assessment would be done after 12 weeks during which all the scales would be re administered.
次要结局
- OUTCOME VARIABLES