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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05675098). StuddyBuddy aggregates publicly available trial information.