Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cognitive Training
• Intervention / Treatment: Procedure: Tablet-based CT; Procedure: Paper-and-pencil CT group

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group 1. Tablet-based CT (NeuroAIreh@b); 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; This group will perform digital CT tasks.
Experimental: Experimental group 2. Paper-and-pencil CT (Task Generator).; 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; This group will perform paper-and-pencil CT tasks.
No Intervention: passive control group (Waiting-list).; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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 Outcome Measures

Outcome Measure	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).
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).

Collaborators and Investigators

• Sponsor: Universidade da Madeira

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 43/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No