Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

NCT05929287 | Completed DMC

• 1 other identifier: 43/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Training

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

Secondary Outcomes (5)

• 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).

• 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).

• 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)

• 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).

• 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).

Study Arms (3)

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.

Procedure: Tablet-based CT

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.

Procedure: Paper-and-pencil CT group

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).

Interventions

Tablet-based CT PROCEDURE

This group will perform digital CT tasks.

Experimental group 1. Tablet-based CT (NeuroAIreh@b)

Paper-and-pencil CT group PROCEDURE

This group will perform paper-and-pencil CT tasks.

Experimental group 2. Paper-and-pencil CT (Task Generator).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of concomitant neurological and/or psychiatric disorders;
• Hemianopsia;
• Unilateral neglect;
• Aphasia syndromes.

Sponsors & Collaborators

• Universidade da Madeira: lead

Study Sites (1)

ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal

Funchal, 9020-105, Portugal

Location

Related Publications (1)

• 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.

  PMID: 41070261 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants won't be aware of which group they are randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: May 2, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)