Executive Functions Rehabilitation in Premature Children

Study Overview
=================
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)

Official Title
-----------------
Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project

Conditions
-----------------
Executive Functions

Intervention / Treatment
-----------------
* Device: Intendu


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: children affected by epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training<br>children submitted to the Intendu training with motion based cognitive video games software | Device: Intendu<br>* intensive training with Motion Based Cognitive Video Games Software<br>|
| No Intervention: no training<br>children not submitted to the training, entering the study as a control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient | the achievement of at least 10 points change of WPPSI® Processing Speed Quotient (subtests: Coding and Symbol search) will be considered significant | assessment at baseline (time 0) and at the end of the training (after 4 weeks) | 
| change in scaled scores of Nepsy II® (developmental Neuropsychological Assessment) attention and executive function domain | the achievement of at least 3 points change in scaled scores of Nepsy II® attention and executive function domain | assessment at baseline (time 0) and at the end of the training (after 4 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature children, processing speed, executive functions