Cognitive Training Cerebral Palsy (ETCONNECT)

Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity

This study aims to conduct a single-blind randomized controlled trial with sixty children with Cerebral Palsy (CP) to explore if a home-based computerized multi-modal executive training is effective improving infants' executive functions (EF), as the primary outcome. As secondary outcomes, it will be tested if the intervention exerts a positive effect on other cognitive functions, social relationships, and quality of life (QOL) in children with CP. It is expected to observe changes in brain structure and functioning associated to clinical improvements.

The primary hypothesis to be tested is that a computerized multi-modal cognitive training will be more effective at improving EF than usual care alone.

Secondary hypotheses are that the computerized therapy will be more effective than usual care alone at improving specific cognitive functions such as visuoperception, memory, social relationships and QOL. In addition, we also hypothesize there will be changes on brain structure and function. We further hypothesise that these changes will be maintained over time (9 months). Finally, sociodemographic and clinical factors are expected to be related with the level of efficacy of the computerized multi-modal cognitive training.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Computerized Executive Functions training; Other: Care as usual

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Facultat de Psicologia (Universitat de Barcelona)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 8-12 years.
• Manual Abilities Classification scale (MACs) ranging from I to III.
• An intelligible yes/no response system.
• Being able to understand simple instructions.
• Having the possibility of participating in the investigation for one year.
• Being able to access to internet at home.

Exclusion Criteria:

• Identified hearing or visual impairment that precludes neuropsychological assessment and training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate intervention group; Thirty children with CP aged 8 to 12 years (or fifteen with neuroimage data) will participate in a computerized executive training program from home (12 weeks, 5 days a week, 30 min a day).	Behavioral: Computerized Executive Functions training; Home-based executive function training with adaptive difficulty, through NeuronUp (https://www.neuronup.com) over 12 weeks (30 min/day, 5 days per week, 30h in total).
Other: Wait-list delayed intervention; Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity.	Other: Care as usual; Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Executive Function	Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Five Digit Test (FDT)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Tower Test, Delis-Kaplan Executive Function System (D-KEFS)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Conners' Continuous Performance Test-II (CPT-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Executive Function	Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Visuoperception	Benton Facial Recognition Test (BFRT)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Visuoperception	Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Memory	Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Memory	Word selective reminding, Test of Memory and Learning (TOMAL)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Participation	Participation and Environment Measure for Children and Youth (PEM-CY)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Quality of Life	Cerebral Palsy Quality of Life (CP QOL-CHILD) questionnaire. CP QOL-CHILD is a proxy-reported questionnaire and QOL is measured as an index score (range from 0 to 100).	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Structural and Functional neuroimaging	Structural and functional (resting state) magnetic resonance images (MRI)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Ministerio de Economía y Competitividad, Spain; Generalitat de Catalunya
• Investigators: Principal Investigator: Roser Pueyo, PhD, University of Barcelona

Publications and helpful links

General Publications

• Garcia-Galant M, Blasco M, Reid L, Pannek K, Leiva D, Laporta-Hoyos O, Ballester-Plane J, Miralbell J, Caldu X, Alonso X, Toro-Tamargo E, Melendez-Plumed M, Gimeno F, Coronas M, Soro-Camats E, Boyd R, Pueyo R. Study protocol of a randomized controlled trial of home-based computerized executive function training for children with cerebral palsy. BMC Pediatr. 2020 Jan 7;20(1):9. doi: 10.1186/s12887-019-1904-x.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Quality of Life; Neuroimaging; Cognitive Training; Participation; Executive Functions; Computerized Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: PSI2016-75979-R AEI/FEDER, UE; 2017SGR748 (Other Grant/Funding Number: Generalitat de Catalunya)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No