Executive Functions Rehabilitation in Premature Children
Primary Purpose
Executive Functions
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intendu
Sponsored by
About this trial
This is an interventional treatment trial for Executive Functions focused on measuring premature children, processing speed, executive functions
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
Sites / Locations
- V. Buzzi Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
training
no training
Arm Description
children submitted to the Intendu training with motion based cognitive video games software
children not submitted to the training, entering the study as a control group
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03639298
First Posted
August 13, 2018
Last Updated
March 31, 2021
Sponsor
Vittore Buzzi Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03639298
Brief Title
Executive Functions Rehabilitation in Premature Children
Official Title
Premature Children-executive Functions and Training With Cognitive Motion-based Videogames (Intendu®): a Rehabilitation Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to SARS-Cov-2 emergency we were unable to recruit the expected number of children. We will analyze the available data
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
September 19, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vittore Buzzi Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Functions
Keywords
premature children, processing speed, executive functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
training
Arm Type
Experimental
Arm Description
children submitted to the Intendu training with motion based cognitive video games software
Arm Title
no training
Arm Type
No Intervention
Arm Description
children not submitted to the training, entering the study as a control group
Intervention Type
Device
Intervention Name(s)
Intendu
Intervention Description
intensive training with Motion Based Cognitive Video Games Software
Primary Outcome Measure Information:
Title
change in WPPSI-III ( Wechsler Preschool and Primary Scale of Intelligence) Processing Speed Quotient
Description
the achievement of at least 10 points change of WPPSI® Processing Speed Quotient (subtests: Coding and Symbol search) will be considered significant
Time Frame
assessment at baseline (time 0) and at the end of the training (after 4 weeks)
Title
change in scaled scores of Nepsy II® (developmental Neuropsychological Assessment) attention and executive function domain
Description
the achievement of at least 3 points change in scaled scores of Nepsy II® attention and executive function domain
Time Frame
assessment at baseline (time 0) and at the end of the training (after 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Scelsa, MD
Organizational Affiliation
V. Buzzi Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
V. Buzzi Children's Hospital
City
Milan
State/Province
MI
ZIP/Postal Code
20154
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
protocol of the study and patient data
Citations:
PubMed Identifier
19081519
Citation
Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009 Jan;8(1):110-24. doi: 10.1016/S1474-4422(08)70294-1.
Results Reference
background
PubMed Identifier
17625996
Citation
Johnson S. Cognitive and behavioural outcomes following very preterm birth. Semin Fetal Neonatal Med. 2007 Oct;12(5):363-73. doi: 10.1016/j.siny.2007.05.004. Epub 2007 Jul 10.
Results Reference
background
PubMed Identifier
20485453
Citation
Dye MW, Green CS, Bavelier D. Increasing Speed of Processing With Action Video Games. Curr Dir Psychol Sci. 2009;18(6):321-326. doi: 10.1111/j.1467-8721.2009.01660.x.
Results Reference
background
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Executive Functions Rehabilitation in Premature Children
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