Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation
Brief summary
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.
Interventions
BEHAVIORALComputerized 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).
OTHERCare as usual
Care as usual
Sponsors
Ministerio de Economía y Competitividad, Spain
Generalitat de Catalunya
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Executive Function | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | Spatial Span, Wechsler Nonverbal Scale of Ability (WNV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Visuoperception | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | Benton Facial Recognition Test (BFRT) |
| Change from baseline Memory | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II) |
| Change from baseline Participation | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | Participation and Environment Measure for Children and Youth (PEM-CY) |
| Change from baseline Quality of Life | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | 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). |
| Change from baseline Structural and Functional neuroimaging | T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training) | Structural and functional (resting state) magnetic resonance images (MRI) |
Countries
Spain
Outcome results
None listed