Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline Executive Function
研究概览
简要总结
This study aims to conduct a single-blind randomized controlled trial with sixty children with Cerebral Palsy (CP) to explore if a home-based computerized multi-modal executive training is effective improving infants' executive functions (EF), as the primary outcome. As secondary outcomes, it will be tested if the intervention exerts a positive effect on other cognitive functions, social relationships, and quality of life (QOL) in children with CP. It is expected to observe changes in brain structure and functioning associated to clinical improvements.
The primary hypothesis to be tested is that a computerized multi-modal cognitive training will be more effective at improving EF than usual care alone.
Secondary hypotheses are that the computerized therapy will be more effective than usual care alone at improving specific cognitive functions such as visuoperception, memory, social relationships and QOL. In addition, we also hypothesize there will be changes on brain structure and function. We further hypothesise that these changes will be maintained over time (9 months). Finally, sociodemographic and clinical factors are expected to be related with the level of efficacy of the computerized multi-modal cognitive training.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8-12 years.
- •Manual Abilities Classification scale (MACs) ranging from I to III.
- •An intelligible yes/no response system.
- •Being able to understand simple instructions.
- •Having the possibility of participating in the investigation for one year.
- •Being able to access to internet at home.
排除标准
- •Identified hearing or visual impairment that precludes neuropsychological assessment and training.
结局指标
主要结局
Change from baseline Executive Function
时间窗: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)
次要结局
- Change from baseline Participation(T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training))
- Change from baseline Quality of Life(T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training))
- Change from baseline Structural and Functional neuroimaging(T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training))
- Change from baseline Visuoperception(T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training))
- Change from baseline Memory(T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training))
研究者
Roser Pueyo
Associate professor
University of Barcelona