Executive Functions Rehabilitation in Premature Children
- Conditions
- Executive Functions
- Interventions
- Device: Intendu
- Registration Number
- NCT03639298
- Lead Sponsor
- Vittore Buzzi Children's Hospital
- Brief Summary
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.
- Detailed Description
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:
35 children born prematurely (23-36.5 W) aged 4-6 year-old with reduced processing speed, will be invited to participate if they meet the inclusion criteria. They will be submitted to 4-5 weeks intensive training with Intendu®, (4-5 sessions per week, for a total of 20 sessions) lasting 15 minutes each, in the presence of a tutor (a psychologist expert in premature children). A control group of 35 children (no training) with the same characteristics (gestational age, cognitive profile, socio-economic status) will be available. Before and after the training/or no training the participants, in addition to the scheduled follow-up assessment, will be evaluated with two WPPSI-III®-Wechsler Preschool and Primary Scale of Intelligence subtests (Coding and Symbol search) and one Nepsy II® domain-A developmental Neuropsychological Assessment (attention and executive function). Teacher and parents evaluations will be also considered (school reports and Child Behavior Checklist - questionnaire)
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
children
- 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
- children affected by epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description training Intendu children submitted to the Intendu training with motion based cognitive video games software
- Primary Outcome Measures
Name Time Method change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
V. Buzzi Children's Hospital
🇮🇹Milan, MI, Italy