Cognitive Training, Stroke
Conditions
Brief summary
This study aims to assess the efficacy of two cognitive training programs - one tablet-based (NeuroAIreh@b) and one in paper-and-pencil format (Task Generator) - in improving cognitive and noncognitive outcomes among community-dwelling stroke survivors. This study will include a waiting-list control group to assess the impact of these interventions and provide further insights into their potential for stroke survivors.
Detailed description
The investigators plan to conduct a multicentric clinical trial with 45 participants randomly assigned to one of three groups. The study will have three arms, with each group receiving one of the following interventions: table-based cognitive training (NeuroAIreh@b), paper-and-pencil cognitive training (Task Generator) or no intervention (waiting-list control group). The latter group will not receive intervention during the study but will be offered the opportunity to participate in one of the cognitive training programs after completing the study. Additionally, the investigators will assess participants at three different time points: before the intervention (pre-intervention), immediately after the intervention (post-intervention), and three months after the intervention (follow-up).
Interventions
PROCEDURETablet-based CT
This group will perform digital CT tasks.
PROCEDUREPaper-and-pencil CT group
This group will perform paper-and-pencil CT tasks.
Sponsors
Universidade da Madeira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants won't be aware of which group they are randomized to.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stroke diagnosis; * Maximum age: 75 years old; * Education: at least three years of formal education; * Relatively preserved language abilities (expressive and receptive language); * Residing in the community; * Availability to go to the hospital 2x/week; * Preserved visual and auditory acuity; * Physically able to operate the tablet and perform the paper-and-pencil training; * Motivation to participate.
Exclusion criteria
* Diagnosis of concomitant neurological and/or psychiatric disorders; * Hemianopsia; * Unilateral neglect; * Aphasia syndromes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Fluency Tests | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | Change from baseline to post-intervention, and baseline to follow-up, in the verbal fluency tests; Min score=0; Max score=dependent on participants' performance during the 1-minute task. Higher scores on the verbal fluency tests are indicative of a better performance. |
| Montreal Cognitive Assessment (MoCA) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | change from baseline to post-intervention, and baseline to follow-up, in the MoCA; Min score=0; Max score=30; Higher are indicative of a better performance; |
| Symbol Search and Digit Symbol (WAIS-III) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) | change from baseline to post-intervention, and baseline to follow-up, in both the Symbol Search and the Digit Symbol (WAIS-III); Min score=0; Max score=Dependent on participants' performance during the 120 seconds tasks. Higher scores in both subtests are indicative of a better performance. |
| Toulouse-Piéron Cancellation Test (TP) | : baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) | change from baseline to post-intervention, and baseline to follow-up, in the TP; Min and Max scores=dependent on participants' performance during 10 minutes. A higher work efficiency index is indicative of a better performance, while a higher dispersion index is indicative of a worse performance. |
| Rey-Complex Figure Test (ROCFT) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) | Change from baseline to post-intervention, and baseline to follow-up, in the ROCFT; Min score=0; Max score=36. Higher scores on both the copy trial and 3-minutes immediate recall trial are indicative of a better performance. |
| Auditory Verbal Learning Test (AVLT) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) | Change from baseline to post-intervention, and baseline to follow-up, in the AVLT; Min score=0; Max score=varies across trials (5 immediate recall trials: 75 points; 1 delayed recall trial: 15 points; 1 delayed recognition task: 30 points). Higher scores are indicative of a better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | Change from baseline to post-intervention, and baseline to follow-up, in the HADS; Min score=0; Max score=42; Higher scores are indicative of worse self-perceived emotional stability. |
| Quality of Life after Brain Injury (QOLIBRI) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) | Change from baseline to post-intervention, and baseline to follow-up, in the QOLIBRI; Min score=0; Max score=100; Higher scores are indicative of greater self-perceived quality of life. |
| Adults and Older Adults Functional Assessment Inventory (IAFAI) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | Change from baseline to post-intervention, and baseline to follow-up, in the IAFAI; Min=0; Max=100; Higher scores are indicative of a worse self-reported functional disability. |
| Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | Change from baseline to post-intervention, and baseline to follow-up, in the MOT-Q; Min=-62; Max=62; Higher scores indicate higher motivation for rehabilitation. |
| Subjective Memory Complaints Questionnaire (SMCQ) | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). | Change from baseline to post-intervention, and baseline to follow-up, in the SMCQ; Min score=0; Max score=21; Higher scores are indicative of worse self-perceived memory decline. |
Countries
Portugal
Outcome results
None listed