Oral drugs for dystonia in children with cerebral palsy
Not Applicable
Completed
- Conditions
- Health Condition 1: G808- Other cerebral palsy
- Registration Number
- CTRI/2020/07/026504
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children aged between 1-18 years
2.Diagnosed as dystonic cerebral palsy
Exclusion Criteria
Patients with one or more of following criterion will be excluded:
1.Received any other medication for dystonia in previous three months
2.Received any of the above two drugs for any other indication in previous three months
3.Presence of significant spasticity (ashworth grade 2 or more)
4.History of allergy to any of the above drugs
5.Genetic or syndromic associations
6.Severe concurrent illness or diseases not associated with cerebral palsy or unstable medical conditions like pneumonia
7.Recent orthopedic surgery/cast/botulinum toxin
8.Caregiver not providing informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in change in mean total BADS scores within 1 week of completing 12 weeks of intervention, between both the armsTimepoint: 12 weeks of intervention
- Secondary Outcome Measures
Name Time Method Difference in change in mean total CP-QOL scores within 1 week of completing 12 weeks of intervention, between participants more then 4 years in both armsTimepoint: 12 weeks;Difference in change in mean total GMFM scores within 1 week of completing 12 weeks of intervention, between participants of 1 to 16 years of age in both armsTimepoint: 12 weeks;Difference in change in mean total QUEST scores within 1 week of completing 12 weeks of intervention, between participants of 18 months to 8 years of age in both arms.Timepoint: 12 weeks;To compare the frequency of mild, moderate, severe and life-threatening adverse effects between both armsTimepoint: 12 weeks