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CompletedNCT05929287Updated Dec 10, 2024

Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

An interventional study of Tablet-based CT and Paper-and-pencil CT group in Stroke and Cognitive Training, sponsored by Universidade da Madeira. Completed at 1 site in Portugal. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Universidade da Madeira · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Stroke
  • Cognitive Training

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03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Universidade da Madeira is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of concomitant neurological and/or psychiatric disorders;
  • Hemianopsia;
  • Unilateral neglect;
  • Aphasia syndromes.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

  • 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).

Interventions

  • ProcedureTablet-based CT

    This group will perform digital CT tasks.

  • ProcedurePaper-and-pencil CT group

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

06

What researchers measure

Primary outcomes

  1. 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;

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

  2. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)

  3. 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.

    Time frame: : baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)

  4. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)

  5. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)

  6. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

Secondary outcomes

  1. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

  2. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

  3. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)

  4. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

  5. 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.

    Time frame: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).

07

Study locations

1 site
  • ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal
    Funchal, 9020-105, Portugal
08

References and documents

Publications

  • 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. PubMed 41070261 ↗

Study documents

  • Protocol and informed consent form · Oct 28, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Jul 2024, 14 months.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 14 months is below that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2023
First posted
Jul 3, 2023
StartActual
May 2, 2023
Primary completionActual
Jul 31, 2024
CompletionActual
Jul 31, 2024
Last update
Dec 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05929287
Lead sponsor
Universidade da Madeira
Responsible party
Sergi Bermúdez i Badia (Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS, Universidade da Madeira) — Principal investigator
First posted
Jul 3, 2023
Start date
May 2, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Dec 10, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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