Comparison of drug effect with placebo in children with abnormal movements

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2019
INTERVENTION: Intervention1: INTERVENTION ARM: After baseline evaluation, the subjects in the intervention arm will be started on trihexyphenidyl according to weight maximum dose upto 1mg/kg/day in divided 3 doses orally, for duration of 12 weeks. Control Intervention1: CONTROL ARM: After baseline evaluation, the subjects in the control arm would be started on placebo (1mg/kg/day) orally in 3 divided doses,for duration of 12weeks. The Placebo will be an inert substance with similar shape, size, colour, taste and smell as Trihexyphenidyl tablets. The schedule would be explained in detail to the parents. CONDITION: Other cerebral palsy PRIMARY OUTCOME: OUTCOME VARIABLES ; ; Change in score on Global Dystonia Scale. ; Change in score on Gross Motor Function Measure‐88 (GMFM‐88). ; 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: OUTCOME VARIABLES ; ; Change in score on Global Dystonia Scale. ; Change in score on Gross Motor Function Measure‐88 (GMFM‐88). ; Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP‐2).Timepoint: Follow Up would be done at 3 weeks and 6 weeks. ; Final assessment would be done after 12 weeks during which all the scales would be re administered. INCLUSION CRITERIA: Residents of Delhi NCR
Epistemonikos ID: cf79544998d6471c4d548c89bb96e09a55f957d0
First added on: Jan 28, 2022