Cognitive Training Cerebral Palsy

Cerebral Palsy Clinical Trial

— ETCONNECT  

Official title:

Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025749
• Other study ID #: PSI2016-75979-R AEI/FEDER, UE
• Secondary ID: 2017SGR748
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Spain	Facultat de Psicologia (Universitat de Barcelona)	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
University of Barcelona	Generalitat de Catalunya, Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Executive Function	Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Five Digit Test (FDT)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Tower Test, Delis-Kaplan Executive Function System (D-KEFS)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Conners' Continuous Performance Test-II (CPT-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Primary	Change from baseline Executive Function	Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Visuoperception	Benton Facial Recognition Test (BFRT)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Visuoperception	Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Memory	Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Memory	Word selective reminding, Test of Memory and Learning (TOMAL)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Participation	Participation and Environment Measure for Children and Youth (PEM-CY)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Quality of Life	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).	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary	Change from baseline Structural and Functional neuroimaging	Structural and functional (resting state) magnetic resonance images (MRI)	T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)