Clinical trial NCT05929287: Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke
Official title: A Comparison Between Personalized and Adaptive Tablet-based Cognitive Training and Paper-and-pencil Cognitive Training: a Randomized Controlled Trial With Community Dwelling Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cognitive Training
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
measure: Symbol Search and Digit Symbol (WAIS-III)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
measure: Toulouse-Piéron Cancellation Test (TP)
timeFrame: : baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
measure: Rey-Complex Figure Test (ROCFT)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
measure: Auditory Verbal Learning Test (AVLT)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
measure: Verbal Fluency Tests
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Secondary outcomes:
measure: Subjective Memory Complaints Questionnaire (SMCQ)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
measure: Quality of Life after Brain Injury (QOLIBRI)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
measure: Adults and Older Adults Functional Assessment Inventory (IAFAI)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
measure: Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)
timeFrame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal
Study officials:
References: