Cognitive Training Cerebral Palsy

Study Overview
=================
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.

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

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: Computerized Executive Functions training
* Other: Care as usual


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate intervention group<br>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<br>* 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).<br>|
| Other: Wait-list delayed intervention<br>Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity. | Other: Care as usual<br>* Care as usual<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Executive Functions, Cognitive Training, Computerized Therapy, Quality of Life, Neuroimaging, Participation