Comparison of drug effect with placebo in children with abnormal movements
Not Applicable
- Conditions
- Health Condition 1: G808- Other cerebral palsy
- Registration Number
- CTRI/2019/02/017481
- Lead Sponsor
- Abhishek S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Residents of Delhi NCR
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OUTCOME VARIABLES <br/ ><br> <br/ ><br>Change in score on Global Dystonia Scale. <br/ ><br>Change in score on Gross Motor Function Measure-88 (GMFM-88). <br/ ><br>Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2).Timepoint: 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.
- Secondary Outcome Measures
Name Time Method OUTCOME VARIABLES <br/ ><br> <br/ ><br>Change in score on Global Dystonia Scale. <br/ ><br>Change in score on Gross Motor Function Measure-88 (GMFM-88). <br/ ><br>Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2).Timepoint: Follow Up would be done at 3 weeks and 6 weeks. <br/ ><br>Final assessment would be done after 12 weeks during which all the scales would be re administered.