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Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

NCT ID: NCT05929287

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Stroke Cognitive Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants won't be aware of which group they are randomized to.

Study Groups

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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.

Group Type EXPERIMENTAL

Tablet-based CT

Intervention Type PROCEDURE

This group will perform digital CT tasks.

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.

Group Type EXPERIMENTAL

Paper-and-pencil CT group

Intervention Type PROCEDURE

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tablet-based CT

This group will perform digital CT tasks.

Intervention Type PROCEDURE

Paper-and-pencil CT group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade da Madeira

OTHER

Sponsor Role lead

Responsible Party

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Sergi Bermúdez i Badia

Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Funchal, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 41070261 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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43/2019

Identifier Type: -

Identifier Source: org_study_id