Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929287
• Other study ID #: 43/2019
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Universidade da Madeira
• Contact: Joana Daniela F Câmara
• Phone: 965441077
• Email: joana.fcamara[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Training
• Stroke

Intervention

Procedure:
• Tablet-based CT
This group will perform digital CT tasks.
• Paper-and-pencil CT group
This group will perform paper-and-pencil CT tasks.

Locations

Country	Name	City	State
Portugal	ARDITI, Edif. Madeira Tecnopolo, Caminho da Penteada piso 2, 9020-105 Funchal	Funchal

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Madeira

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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).
Secondary	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).
Secondary	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)
Secondary	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).
Secondary	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).