Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy

Cerebral Palsy (CP) is a neurological disorder that commonly cause disability and limit physical function in children, and this disability persists into adulthood. There are several treatment options for motor impairments associated with CP, including oral medications (diazepam or related benzodiazepines, baclofen, dantrolene, and tizanidine hydrochloride), intraspinal infusion (baclofen), paralyzing agents (Botulinum toxin), and surgical interventions (dorsal rhizotomy). However, these interventions have drawbacks that could impact their benefits, such as drowsiness with oral medications and permanent change in muscle tone with the rhizotomy surgery. Other rehabilitation interventions showed significant improvements in motor function such as constraint-induced movement therapy (CIMT) and strength training. A few researchers attempted using central nervous system stimulants (i.e., Modafinil \[Provigil\]) off-label for improving motor control and reducing spasticity in children with CP. Another medication that has been used for motor impairments is Methylphenidate (MPH), also a central nervous system stimulant. However, this medication was used for improving muscle tone and motor performance in children with Attention-deficit/Hyperactivity Disorder (ADHD), but not in children with CP. MPH is useful for children with combined CP and ADHD and showed beneficial results for ADHD symptoms and behavioral outcomes with minimal side effects. Therefore, the purpose of this pilot randomized controlled trial (RCT) is to examine the effects of Central Nervous System (CNS) stimulants (Modafinil and MPH) vs. placebo in addition to physical therapy intervention on gross motor function and spasticity in children with CP.

• Body height [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• Timed up and go (TUG) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• Five times sit to stand test (5x Sit-To-Stand Test /5XSST) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• Modified clinical test for sensory interaction of balance (MCTSIB) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• Ten-meter walk test (10MWT) (normal pace) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• 2-Minutes Walking Test (normal pace) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
• Body weight [Срок оценки: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]