Congenital or acquired brain injury Nervous System Diseases
Conditions
Interventions
The study applies a randomized controlled trial design, randomly assigning patients to one of two groups undergoing two different rehabilitation programs: Group 1 receives the social prediction VR tra
Sponsors
Scientific Institute (IRCCS) Eugenio Medea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/12/2018: Children, adolescents and young adults (aged between 7 and 25 and IQ >45) with a congenital or acquired cerebellar disease who had been referred to the Child Neuropsychiatry and Neurorehabilitation Unit of the Scientific Institute IRCCS E. Medea in the last years Previous inclusion criteria: Children and adolescents (aged between 8 and 16 and IQ >60) with a congenital or acquired cerebellar disease who had been referred to the Child Neuropsychiatry and Neurorehabilitation Unit of the Scientific Institute IRCCS E. Medea in the last years
Exclusion criteria
Exclusion criteria: 1. Severe sensorial, motor and/or behavioral problems that could interfere with the use of Grail technology 2. Being simultaneously involved in a different cognitive rehabilitation treatment, to avoid excessive demands to children and possible interference on training adherence rates 3. Having been involved in a different cognitive rehabilitation treatment in the last six months before training, to avoid confounding follow-up effects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Training feasibility, assessed using: 1. Number of dropouts: number of children who renounce to complete the two-weeks training 2. Number of sessions completed per child: total number of sessions done in front of the total number proposed of eight sessions. Timepoint: two weeks (T1-after training conclusion) Training acceptability, assessed using: 1. Acceptability questionnaire: an ad hoc questionnaire completed by participants and another one by their parents after training conclusion to assess subjective evaluation of training accessibility and efficacy. Timepoint: two weeks (T1-after training conclusion) Primary outcome measure: 1. Participants' performance during the VR social prediction training (scores in each session, duration per trial, mean speed); Timepoints: daily during the training 2. Social prediction ability: performance during the pre and post-training evaluation in the “sweet stands” scenario; Timepoints: measured at baseline (T0) and two weeks (T1-after training conclusion); accuracy and reaction time in the testing phase of a validated PC-based Action prediction task (Amoruso et al., 2016). Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Social cognition: Theory of mind Part A and B and Emotion recognition of NEPSY-II testing battery (Korkman et al., 2011). Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 2. Implicit learning: accuracy and reaction time in the familiarization phase of an Action prediction task (Amoruso et al., 2016). Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 3. Executive functions (inhibition and flexibility): Inhibition test of NEPSY-II. Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 4. Visual attention: Visual attention test of NEPSY-II. Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 5. Visuospatial and visual-perceptual abilities: Geometric Puzzle and Picture Puzzle tests of NEPSY-II. Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up). 6. Memory: Memory for drawings test of NEPSY-II. Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 7. Sensorimotor functions: Fingers-tapping test of NEPSY-II. Timepoints: measured at baseline (T0); two weeks (T1-after training conclusion); two months (T2-follow-up) 8. Behavioral problems: CBCL 6-18, Parent version (Achenbach & Rescorla, 2001; http://www.aseba.org). Timepoints: measured at baseline (T0); two months (T2-follow-up) 9. Overall functioning and quality of life assessed using the TACQOL (TNO Quality of life / LUMC, 2001) that assess quality of life, health and well-being of patients in several areas. This questionnaire is presented in two forms: the self-compiled and the parent-compiled one. Timepoints: measured at baseline (T0); two months (T2-follow-up) | — |
Countries
Italy
Outcome results
None listed