Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Arithmetic task from WISC-IV testing battery
研究概览
简要总结
The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Receiving ADHD diagnosis
- •aged between 9 and 12 years
- •Intelligence Quotient (IQ)>90
排除标准
- •Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder
- •A history of seizures during past 2 years
- •Disability or handicap preventing the child from participating cognitive-motor exercises
- •Sever medical conditions requiring immediate medical treatment
研究组 & 干预措施
Cognitive-Motor Rehabilitation
Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation
干预措施: Cognitive-Motor Rehabilitation (Other)
Ritalin
2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.
干预措施: Ritalin (Drug)
Active Control
Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
干预措施: Active Control (Other)
结局指标
主要结局
Arithmetic task from WISC-IV testing battery
时间窗: 12 months
Dictation and Spelling examination
时间窗: 12 months
Stroop color-word test
时间窗: 12 months
Tower of London test (TOL)
时间窗: 12 months
Restricted academic situation scale (RASS)
时间窗: 12 months
Listening span task (L.SPAN)
时间窗: 12 months
Span board task from the Lumosity.com online brain training software
时间窗: 12 months
Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)
时间窗: 12 months
Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Saeed Azami
Mr.
Allameh Tabatabai University