Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gross motor function measure (GMFM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
- •Children that use medications that interfere with spasticity (e.g., Baclofen)
研究组 & 干预措施
Methylphenidate
Participants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program
干预措施: Methylphenidate (Drug)
Modafinil
Participants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program
干预措施: Modafinil (Drug)
Placebo
Participants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program
干预措施: Placebo (Other)
结局指标
主要结局
Gross motor function measure (GMFM)
时间窗: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
To determine changes in functional motor abilities.
Modified Ashworth Scale (MAS)
时间窗: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
To determine changes in spasticity
次要结局
- Body height(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- 2-Minutes Walking Test (normal pace)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- Body weight(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- Timed up and go (TUG)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- Five times sit to stand test (5x Sit-To-Stand Test /5XSST)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- Modified clinical test for sensory interaction of balance (MCTSIB)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
- Ten-meter walk test (10MWT) (normal pace)(Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention)
研究者
Dr. Anwar Amutairi
Assistant Professor
Kuwait University