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Completed

NCT Number: NCT04025749

Cognitive Training Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultat de Psicologia (Universitat de Barcelona)

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computerized Executive Functions training

Behavioral

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).

Care as usual

Other

Care as usual

Primary outcomes

  1. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)

  2. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)

  3. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Five Digit Test (FDT)

  4. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)

  5. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)

  6. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Tower Test, Delis-Kaplan Executive Function System (D-KEFS)

  7. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Conners' Continuous Performance Test-II (CPT-II)

  8. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)

  9. Change from baseline Executive Function

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)

  10. Change from baseline Executive Function

    Time frame: 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 outcomes

  1. Change from baseline Visuoperception

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Benton Facial Recognition Test (BFRT)

  2. Change from baseline Visuoperception

    Time frame: 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)

  3. Change from baseline Memory

    Time frame: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

    Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)

  4. Change from baseline Memory

    Time frame: 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)

  5. Change from baseline Participation

    Time frame: 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)

  6. Change from baseline Quality of Life

    Time frame: 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).

  7. Change from baseline Structural and Functional neuroimaging

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Generalitat de Catalunya
  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

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

Acronym: ETCONNECT

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2019
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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