Executive Functions Rehabilitation in Premature Children

NCT03639298 | Terminated

• 1 other identifier: BS1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Functions

Keywords

premature children; processing speed; executive functions

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

training

EXPERIMENTAL

children submitted to the Intendu training with motion based cognitive video games software

Device: Intendu

no training

NO INTERVENTION

children not submitted to the training, entering the study as a control group

Interventions

Intendu DEVICE

intensive training with Motion Based Cognitive Video Games Software

training

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• children affected by epilepsy

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Study Sites (1)

V. Buzzi Children's Hospital

Milan, MI, 20154, Italy

Location

Related Publications (3)

• 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.

  PMID: 19081519 BACKGROUND

• 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.

  PMID: 17625996 BACKGROUND

• 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.

  PMID: 20485453 BACKGROUND

Study Officials

• Barbara Scelsa, MD

  V. Buzzi Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: September 11, 2018
• Primary Completion: September 19, 2020
• Study Completion: October 20, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)