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Comparison of drug effect with placebo in children with abnormal movements

TRIHEXYPHENIDYL FOR TREATMENT OF DYSTONIA IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED PLACEBO CONTROLLED TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017481
Enrollment
50
Registered
2019-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G808- Other cerebral palsy

Interventions

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

Sponsors

Abhishek S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Residents of Delhi NCR

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactAbhishek

Maulana Azad Medical College

drmonicajuneja@gmail.com9968604311

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026