Cognitive Training Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: Computerized Executive Functions training; Other: Care as usual

• Registration Number: NCT04025749
• Lead Sponsor: University of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-13
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-19
• Primary Completion: 2021-07-16
• Study Completion: 2022-01-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate intervention group	Computerized Executive Functions training	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).
Wait-list delayed intervention	Care as usual	Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity.

Primary Outcome Measures

Name	Time	Method
Change from baseline Executive Function	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)	Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Secondary Outcome Measures

Name	Time	Method
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 Visuoperception	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)	Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Memory	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)	Word selective reminding, Test of Memory and Learning (TOMAL)
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)

Trial Locations

Locations (1)

Facultat de Psicologia (Universitat de Barcelona); 🇪🇸 Barcelona, Spain