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Cognitive Training Cerebral Palsy (ETCONNECT)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Computerized Executive Functions training
Care as usual
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Facultat de Psicologia (Universitat de Barcelona)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate intervention group

Wait-list delayed intervention

Arm 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).

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

Outcomes

Primary Outcome Measures

Change from baseline Executive Function
Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)
Change from baseline Executive Function
Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Change from baseline Executive Function
Five Digit Test (FDT)
Change from baseline Executive Function
Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Executive Function
Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Executive Function
Tower Test, Delis-Kaplan Executive Function System (D-KEFS)
Change from baseline Executive Function
Conners' Continuous Performance Test-II (CPT-II)
Change from baseline Executive Function
Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Executive Function
Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Executive Function
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Secondary Outcome Measures

Change from baseline Visuoperception
Benton Facial Recognition Test (BFRT)
Change from baseline Visuoperception
Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Memory
Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Change from baseline Memory
Word selective reminding, Test of Memory and Learning (TOMAL)
Change from baseline Participation
Participation and Environment Measure for Children and Youth (PEM-CY)
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).
Change from baseline Structural and Functional neuroimaging
Structural and functional (resting state) magnetic resonance images (MRI)

Full Information

First Posted
June 11, 2019
Last Updated
November 2, 2022
Sponsor
University of Barcelona
Collaborators
Ministerio de Economía y Competitividad, Spain, Generalitat de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04025749
Brief Title
Cognitive Training Cerebral Palsy
Acronym
ETCONNECT
Official Title
Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
Ministerio de Economía y Competitividad, Spain, Generalitat de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate intervention group
Arm Type
Experimental
Arm 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).
Arm Title
Wait-list delayed intervention
Arm Type
Other
Arm Description
Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Executive Functions training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
Care as usual
Primary Outcome Measure Information:
Title
Change from baseline Executive Function
Description
Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Five Digit Test (FDT)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Tower Test, Delis-Kaplan Executive Function System (D-KEFS)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Conners' Continuous Performance Test-II (CPT-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Executive Function
Description
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Secondary Outcome Measure Information:
Title
Change from baseline Visuoperception
Description
Benton Facial Recognition Test (BFRT)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Visuoperception
Description
Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Memory
Description
Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Memory
Description
Word selective reminding, Test of Memory and Learning (TOMAL)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Participation
Description
Participation and Environment Measure for Children and Youth (PEM-CY)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Quality of Life
Description
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).
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Title
Change from baseline Structural and Functional neuroimaging
Description
Structural and functional (resting state) magnetic resonance images (MRI)
Time Frame
T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roser Pueyo, PhD
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultat de Psicologia (Universitat de Barcelona)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31910803
Citation
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.
Results Reference
derived

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Cognitive Training Cerebral Palsy

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