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NCT05675098
Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy
Conditions: Neurodevelopmental Disorders, Cerebral Palsy
Sex: All
Ages: 7 Years – 12 Years
Phase: EARLY_PHASE1
Enrollment: 30
Sponsor: Kuwait University
Location: Kuwait
Summary
The purpose of this study is to determine the effects of Central Nervous System Stimulants, represented by Methylphenidate and Modafinil, compared to placebo control on motor performance in children with Cerebral Palsy.
This study will be a triple-masked study per the American Academy of Neurology guidelines for clinical trials.
Eligibility Criteria
Inclusion Criteria:Children diagnosed with spastic diplegic or quadriplegic CP by a physician.Children aged between 7-12 years old.Children with CP classified as level I & II based on the gross motor function classification system (GMFCS).Children with CP that are receiving physical therapy for ≥ 3 months.Exclusion Criteria:Children that had a seizure attack in the past 6 monthsChildren that have been diagnosed with attention deficit/ hyperactivity disorder (ADHD)Children that had any surgery within the last 6 monthsChildren that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles)Children that use medications that interfere with spasticity (e.g., Baclofen)
Source: ClinicalTrials.gov (NCT05675098). StuddyBuddy aggregates publicly available trial information.