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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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).
Care as usual
Facultat de Psicologia (Universitat de Barcelona)
Barcelona, Spain
Change from baseline Executive Function
Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Visuoperception
Benton Facial Recognition Test (BFRT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
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