Effectiveness of the drug Trihexyphenidyl for abnormal movements in children with Cerebral Palsy
Phase 1
- Conditions
- Health Condition 1: G00-G99- Diseases of the nervous system
- Registration Number
- CTRI/2018/01/011571
- Lead Sponsor
- Maulana Azad Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in score on Global Dystonia Scale <br/ ><br>2.Change in score on Gross Motor Function Measure-88 (GMFM-88) <br/ ><br>3.Change in score on Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2) <br/ ><br>Timepoint: Score will be assessed after 12 weeks that is 3months
- Secondary Outcome Measures
Name Time Method 1.Change in score on Global Dystonia Scale <br/ ><br>2.Change in score on Gross Motor Function Measure-88 (GMFM-88) <br/ ><br>3.Change in score on Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2) <br/ ><br>Timepoint: score will be assessed after 12 weeks that is after 3months