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Cognitive Training Cerebral Palsy

NCT04025749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

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

Care as usual

Care as usual

Sponsors & Collaborators

  • Ministerio de Economía y Competitividad, Spain

    collaborator OTHER_GOV

  • Generalitat de Catalunya

    collaborator UNKNOWN

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Roser Pueyo, PhD · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2021-07-16
Completion
2022-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025749 on ClinicalTrials.gov