Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

Not Applicable

Completed

• Conditions: Stroke; Cognitive Training
• Interventions: Procedure: Tablet-based CT; Procedure: Paper-and-pencil CT group

• Registration Number: NCT05929287
• Lead Sponsor: Universidade da Madeira

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).

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 1. Tablet-based CT (NeuroAIreh@b)	Tablet-based CT	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.
Experimental group 2. Paper-and-pencil CT (Task Generator).	Paper-and-pencil CT group	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.

Primary Outcome Measures

Name	Time	Method
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;
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal; 🇵🇹 Funchal, Portugal