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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1. Tablet-based CT (NeuroAIreh@b) | Experimental | Participants in the NeuroAIreh@b group will perform tablet-based CT tasks personalized to their underlying deficits and performance in each iteration. Biweekly 30-minute sessions until reaching 12 sessions. |
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| Experimental group 2. Paper-and-pencil CT (Task Generator). | Experimental | Participants in the paper and pencil group will perform CT tasks personalized to their cognitive deficits (according to the MoCA) and generated automatically through the Task Generator website (https://neurorehablab.arditi.pt/TaskGenerator/). Biweekly 30-minute sessions until reaching 12 sessions. |
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| passive control group (Waiting-list). | No Intervention | Participants in this group will not be enrolled in any intervention during the course of the study. At the end of the study, participants can integrate a CT intervention of their choice (e.g., CT through the NeuroAIreh@b platform or the TG). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet-based CT | Procedure | This group will perform digital CT tasks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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; | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
| Symbol Search and Digit Symbol (WAIS-III) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) |
| Toulouse-Piéron Cancellation Test (TP) | 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. | : baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) |
| Rey-Complex Figure Test (ROCFT) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) |
| Auditory Verbal Learning Test (AVLT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Memory Complaints Questionnaire (SMCQ) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal | Funchal | 9020-105 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41070261 | Derived | Camara J, de Aguiar SC, Paulino T, Faria AL, Bermudez I Badia S, Vilar M, Ferme E. Comparing adaptive tablet-based cognitive training and paper-and-pencil cognitive training: a pilot randomized controlled trial with community-dwelling stroke survivors. Int J Clin Health Psychol. 2025 Jul-Sep;25(3):100627. doi: 10.1016/j.ijchp.2025.100627. Epub 2025 Sep 25. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 28, 2019 | Jun 23, 2023 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants won't be aware of which group they are randomized to.
| Paper-and-pencil CT group | Procedure | This group will perform paper-and-pencil CT tasks. |
|
| baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) |
| Verbal Fluency Tests | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
| Hospital Anxiety and Depression Scale (HADS) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
| Quality of Life after Brain Injury (QOLIBRI) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months) |
| Adults and Older Adults Functional Assessment Inventory (IAFAI) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
| Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q) | 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. | baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |