Cognitive Training Cerebral Palsy (ETCONNECT)

University of Barcelona

Status: Completed

Conditions: Cerebral Palsy

Treatments: Behavioral: Computerized Executive Functions training; Other: Care as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04025749

PSI2016-75979-R AEI/FEDER, UE

2017SGR748 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Immediate intervention group

Experimental group

Description:

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).

Treatment:

Behavioral: Computerized Executive Functions training

Wait-list delayed intervention

Other group

Description:

Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity.

Treatment:

Other: Care as usual