Clinical trial NCT04025749: Cognitive Training Cerebral Palsy
Official title: Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Executive Functions
Cognitive Training
Computerized Therapy
Quality of Life
Neuroimaging
Participation
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Generalitat de Catalunya
First posted: 2019-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Executive Function
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary outcomes:
measure: Change from baseline Visuoperception
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Visuoperception
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Memory
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Memory
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Participation
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Quality of Life
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
measure: Change from baseline Structural and Functional neuroimaging
timeFrame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Facultat de Psicologia (Universitat de Barcelona)
Study officials:
affiliation: University of Barcelona
name: Roser Pueyo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.