Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age7-12
SponsorKuwait University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children that had a seizure attack in the past 6 months
Children that have been diagnosed with attention deficit/ hyperactivity disorder (ADHD)
Children that had any surgery within the last 6 months
Children that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles)
Trial design
Design model
Parallel
Treatments tested in this trial
Methylphenidate
DrugThis medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
Modafinil
DrugThis medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy
Placebo
Other interventionParticipant will receive placebo tablets (Methylphenidate and Modafinil shape)
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: MethylphenidateExperimental treatment 1 intervention
Group B: ModafinilExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gross motor function measure (GMFM)
To determine changes in functional motor abilities.
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention2
Modified Ashworth Scale (MAS)
To determine changes in spasticity
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after interventionSecondary outcomes
1
Body height
To determine body height
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention2
Timed up and go (TUG)
To assess dynamic balance
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention3
Five times sit to stand test (5x Sit-To-Stand Test /5XSST)
To assess the change in functional strength
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention4
Modified clinical test for sensory interaction of balance (MCTSIB)
To assess static balance
Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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