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Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

U

Universidade da Madeira

Status

Completed

Conditions

Stroke
Cognitive Training

Treatments

Procedure: Paper-and-pencil CT group
Procedure: Tablet-based CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05929287
43/2019

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Experimental group 1. Tablet-based CT (NeuroAIreh@b)
Experimental group
Description:
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.
Treatment:
Procedure: Tablet-based CT
Experimental group 2. Paper-and-pencil CT (Task Generator).
Experimental group
Description:
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.
Treatment:
Procedure: Paper-and-pencil CT group
passive control group (Waiting-list).
No Intervention group
Description:
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).

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Joana Daniela F Câmara

Data sourced from clinicaltrials.gov

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