Congenital or acquired brain injury Nervous System Diseases
Conditions
Interventions
The study applies a stepped-wedge research design, randomly assigning patients to one of 2 groups providing different research conditions: Group 1 (G1) receives the training for 8 weeks, followed by a
Group 2 (G2) remains in stand-by list for 8 weeks (no-treatment) and then receives the cognitive training for the following 8 weeks. More specifically, all participants are initially evaluated through
Sponsors
Scientific Institute (IRCCS) Eugenio Medea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are recruited among the adolescents with a congenital or acquired brain injury who had been referred to the Neurorehabilitation Units of the Scientific Institute IRCCS E. Medea in the last year. Patients with acquired brain injury are considered eligible for the study only if they are in a chronical phase (i.e., at least 1 year post-injury). For the whole sample, inclusion criteria for eligibility are: 1. An age between 11 and 16 years, as in this age-range cognitive requests are generally elevated and individuals are usually able to use technological devices 2. Being native Italian speakers, as in this study demonstrations and instructions on training games were provided in Italian language
Exclusion criteria
Exclusion criteria: 1. Severe sensory or motor deficits that could not be corrected through compensatory tools and could interfere with training execution and assessment 2. Being simultaneously involved in a different cognitive rehabilitation treatment, to prevent excessive demands to children and possible interference on training adherence rates 3. A diagnosis of photosensitive epilepsy, as computer-based stimulation could produce negative health effects in these patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess training feasibility: 1. Number of dropouts: number of children who renounce to complete the 8-week training 2. Number of sessions completed per child: total number of sessions done in front of the total number proposed of 40 sessions To assess training acceptability: 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. Primary outcome measure: Visual-spatial working memory, assessed by Corsi block tapping task. All selected exercises of the training require the manipulation of the visual-spatial information and all of them, except for the game “Lost in Migration” stimulating attention, require the intervention of working-memory competencies. Children are required to indicate a visual-spatial sequence in the same order it was presented by the examiner. A z score will be collected. Outcome measures collected at all assessment points for both groups of participants (T1;T2; T3; T4 for Group 1 and T1; T2; T3; T5 for Group 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Flexibility, assessed using the Wisconsin Card Sorting Test. In this test, children are requested to identify a rule for associating cards and then to modify it on the basis of a computerized feedback. WCST measures difficulties in selecting flexible strategies and in blocking an automatic responding, abilities that are central for flexible thinking. Adjusted standard scores for number of total errors, perseverative responsive and perseverative errors will be collected. 2. Speed, assessed using the reaction time index (HRT) of Conners’ Continuous Performance Test III, measuring time response to a visual attention task. During this task, children are requested to press as fast as possible a button on the computer board in front of the presentation of any alphabetical letters comparing on the screen, except for letter X. 3. Attention, assessed using the visual attention task of Conners’ Continuous Performance Test III. This attentional task ask children to press a button on the computer board in front of the presentation of any alphabetical letters comparing on the screen, but not letter X. Omissions, commissions and perseverations at this task are automatically counted by the program and T-scores are collected. 4. Problem-solving, assessed using the problem solving and/or the arithmetical calculation tasks of the Italian battery AC-MT are used. An age-appropriate task is provided to each subject. 5. Adjustment and psychosocial functioning, assessed using Child Behavior Checklist 6-18 (Achenbach & Rescorla, 2001; http://www.aseba.org) completed by parents; Youth Self-report (Achenbach, 1991; http://www.aseba.org ) completed by children; Teacher Report (Achenbach & Rescorla, 2001; http://www.aseba.org ) completed by teachers. These instruments yield scores on internalizing, externalizing and total psychological problems of children. 6. Overall functioning | — |
Countries
Italy
Outcome results
None listed