Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient
研究概览
简要总结
in more than 60% of premature children processing speed and academic failures are observed, even in children with a normal cognitive level.
The aim of the study is to use for rehabilitation an application for training functional cognitive skills (Intendu®). It is a software which is able to interact with the patient through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
详细描述
In Europe 6.2% of the births are born before 37 weeks of gestation. After a long period in Neonatal Intensive Care Units, the infants are dismissed but they continue to be examined in follow-up programs. It is known that advances in care have improved the rate of survival of premature newborns, but unfortunately they may have disabilities which can be severe (cerebral palsy) or mild. Mild disabilities (like attention deficit, hyperactivity, visual-perceptual and coordination disorders), even if mild, can have a significant impact on school achievements and social life. Follow-up program is dedicated to detect both severe and minor disabilities, trying to rehabilitate the children before they start formal education in school. It is well known that more than half of premature children can show impairment of processing speed and academic failures, even with normal cognitive level. Processing speed is the result of the action of different executive functions, especially working memory, planning, attention shift, inhibition and persistence.
There is growing interest over cognitive rehabilitation with video games. Recently an application for training functional cognitive skills (Intendu®) has been developed . It is a software which is able to interact with patients through a video monitoring feedback (Kinect®), enhancing brain plasticity of patients with brain dysfunction.
Aim of the study:
To evaluate whether an adaptive motion-interaction video game can improve processing speed and executive functions in premature children.
Methods:
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born between 23-36.5 weeks of gestation
- •age between 4 and 0 month -6 years and 11 months
- •included in the V, Buzzi children's Hospital follow-up program
- •resident no further than 20 km from the V. Buzzi Children's Hospital
- •with WPPSI-III processing speed quotient of 91 or less
排除标准
- •children affected by epilepsy
结局指标
主要结局
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient
时间窗: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
the achievement of at least 10 points change of WPPSI® Processing Speed Quotient (subtests: Coding and Symbol search) will be considered significant
change in scaled scores of Nepsy II® (developmental Neuropsychological Assessment) attention and executive function domain
时间窗: assessment at baseline (time 0) and at the end of the training (after 4 weeks)
the achievement of at least 3 points change in scaled scores of Nepsy II® attention and executive function domain
次要结局
未报告次要终点
研究者
Barbara Scelsa
MD
Vittore Buzzi Children's Hospital