NCT04025749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

June 11, 2019

Last Update Submit

November 2, 2022

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyExecutive FunctionsCognitive TrainingComputerized TherapyQuality of LifeNeuroimagingParticipation

Outcome Measures

Primary Outcomes (10)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (7)

  • Change from baseline Visuoperception

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

  • Change from baseline Visuoperception

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

  • Change from baseline Memory

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

  • Change from baseline Memory

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

  • Change from baseline Participation

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

  • +2 more secondary outcomes

Study Arms (2)

Immediate intervention group

EXPERIMENTAL

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).

Behavioral: Computerized Executive Functions training

Wait-list delayed intervention

OTHER

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

Other: Care as usual

Interventions

Computerized Executive Functions trainingBEHAVIORAL

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).

Immediate intervention group
Care as usualOTHER

Care as usual

Wait-list delayed intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Identified hearing or visual impairment that precludes neuropsychological assessment and training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultat de Psicologia (Universitat de Barcelona)

Barcelona, 08035, Spain

Location

Related Publications (3)

  • Garcia-Galant M, Blasco M, Moral-Salicru P, Soldevilla J, Ballester-Plane J, Laporta-Hoyos O, Caldu X, Miralbell J, Alonso X, Toro-Tamargo E, Melendez-Plumed M, Gimeno F, Leiva D, Boyd RN, Pueyo R. Understanding social cognition in children with cerebral palsy: exploring the relationship with executive functions and the intervention outcomes in a randomized controlled trial. Eur J Pediatr. 2024 Sep;183(9):3997-4008. doi: 10.1007/s00431-024-05635-y. Epub 2024 Jun 29.

    PMID: 38951253DERIVED

  • Garcia-Galant M, Blasco M, Laporta-Hoyos O, Berenguer-Gonzalez A, Moral-Salicru P, Ballester-Plane J, Caldu X, Miralbell J, Alonso X, Medina-Cantillo J, Povedano-Bullo E, Leiva D, Boyd RN, Pueyo R. A randomized controlled trial of a home-based computerized executive function intervention for children with cerebral palsy. Eur J Pediatr. 2023 Oct;182(10):4351-4363. doi: 10.1007/s00431-023-05072-3. Epub 2023 Jul 18.

    PMID: 37462799DERIVED

  • Garcia-Galant M, Blasco M, Reid L, Pannek K, Leiva D, Laporta-Hoyos O, Ballester-Plane J, Miralbell J, Caldu X, Alonso X, Toro-Tamargo E, Melendez-Plumed M, Gimeno F, Coronas M, Soro-Camats E, Boyd R, Pueyo R. Study protocol of a randomized controlled trial of home-based computerized executive function training for children with cerebral palsy. BMC Pediatr. 2020 Jan 7;20(1):9. doi: 10.1186/s12887-019-1904-x.

    PMID: 31910803DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Roser Pueyo, PhD

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 11, 2019

First Posted

July 19, 2019

Study Start

November 13, 2017

Primary Completion

July 16, 2021

Study Completion

January 31, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

ES(1)