Executive Functions Rehabilitation in Premature Children

March 31, 2021 updated by: Barbara Scelsa, Vittore Buzzi Children's Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20154
        • V. Buzzi Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: training
children submitted to the Intendu training with motion based cognitive video games software
Device: Intendu
intensive training with Motion Based Cognitive Video Games Software
NO_INTERVENTION: no training
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
Time Frame: 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
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
Time Frame: 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
assessment at baseline (time 0) and at the end of the training (after 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vittore Buzzi Children's Hospital

Investigators

  • Principal Investigator: Barbara Scelsa, MD, V. Buzzi Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 2018

Primary Completion (ACTUAL)

September 19, 2020

Study Completion (ACTUAL)

October 20, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (ACTUAL)

August 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

protocol of the study and patient data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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