Cerebral PalsyETCONNECTNCT04025749
Cognitive Training Cerebral Palsy
A study testing Computerized Executive Functions training and Care as usual in people with Cerebral Palsy, run by University of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Computerized Executive Functions training and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2017to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Identified hearing or visual impairment that precludes neuropsychological assessment and training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity
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.
- Conditions
- Cerebral Palsy
- Being tested
- Computerized Executive Functions training, Care as usual
- Keywords
- Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Executive Functions trainingBehavioural
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 usualOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Executive Function
Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Benton Facial Recognition Test (BFRT)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Visuoperception
Arrows, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Memory
Memory for designs, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Memory
Word selective reminding, Test of Memory and Learning (TOMAL)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Participation
Participation and Environment Measure for Children and Youth (PEM-CY)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
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).
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Change from baseline Structural and Functional neuroimaging
Structural and functional (resting state) magnetic resonance images (MRI)
Measured: T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start13 Nov 2017
- Primary completion16 Jul 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Generalitat de Catalunya
- Responsible party
- Principal investigator, Roser Pueyo, University of Barcelona
- Investigators
- Roser Pueyo, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025749
- Sponsor's protocol ID
- PSI2016-75979-R AEI/FEDER, UE
- Other IDs
- 2017SGR748
- Acronym
- ETCONNECT
- Status last verified
- Nov 2022
- First submitted
- 11 Jun 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38951253Garcia-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.
PubMed 37462799Garcia-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.
PubMed 31910803
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity
- ClinicalTrials.gov ID
- NCT04025749
- Acronym / sponsor ID
- ETCONNECT / PSI2016-75979-R AEI/FEDER, UE
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Generalitat de Catalunya
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention group | Experimental | Behavioral: Computerized Executive Functions trainingThirty 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). |
| Wait-list delayed intervention | Other | Other: Care as usualThirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Identified hearing or visual impairment that precludes neuropsychological assessment and training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Executive Functions trainingHome-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). | Behavioural | Immediate intervention group |
| Care as usualCare as usual | Other | Wait-list delayed intervention |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 38951253Garcia-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.
- Derived from this study: PubMed 37462799Garcia-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.
- Derived from this study: PubMed 31910803Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roser Pueyo, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Executive Functions training and Care as usual in people with Cerebral Palsy, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025749, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.