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Executive Functions Rehabilitation in Premature Children

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03639298
Enrollment
70
Registered
2018-08-21
Start date
2018-09-11
Completion date
2020-10-20
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Executive Functions

Keywords

premature children, processing speed, executive functions

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)

Interventions

DEVICEIntendu

intensive training with Motion Based Cognitive Video Games Software

Sponsors

Vittore Buzzi Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotientassessment 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 domainassessment 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026