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
Phase: NA
Conditions: Stroke, Cognitive Training
Sponsor: Universidade da Madeira

Study protocol 
 
 
 
 
 
 
 
 
 
 
 
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 
Unique protocol: 43/2019 
Document data: 28th of October 2019 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
“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” 
 
Protocol for a randomized controlled trial: 
Stroke is the second leading cause of death and disability worldwide. Post-stroke cognitive 
impairment is highly prevalent and disabling, affecting individuals’ emotional state, quality of life, 
and functional abilities. 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.  
Stroke survivors will be recruited at Funchal Central Hospital (Hospital Central do Funchal – 
Dr. Nélio Mendonça). All participants who agree to participate in the study must give verbal and 
written informed consent according to the model available in annex 1. Importantly, participants 
can cease their collaboration at any time. 
The investigators expect to recruit 45 participants for this study: 
 15 participants for the tablet-based cognitive training group (NeuroAIreh@b) 
(experimental group 1); 
 15 participants for the paper-and-pencil cognitive training group (Task 
Generator) (experimental group 2); 
 15 participants for the waiting-list control group (passive control group). 
Design 
 
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. 
Procedure: 

Study protocol 
Eligible participants will be randomly allocated to one of the three groups.  
Participants in the experimental groups, i.e., NeuroAIreh@b and Task Generator 
groups, will perform 12 bi-weekly sessions, lasting 30 minutes each, for a total of six 
weeks.  
Finally, participants in the waiting-list control group will not be enrolled in any 
intervention during the course of the study. At the end of the study, these participants 
will be granted the possibility of enrolling in an intervention of their choice. 
Neuropsychological assessment:   
The neuropsychological assessment will be performed at three different timings: 
• Baseline: at least one one week prior to study commencement; 
• Post-intervention: at least one week after the end of the interventions; 
• Follow-up: after three months since the post-intervention. 
The clinical assessment will consist of the administration of several performance-based 
instruments and self-report scales that are validated for the Portuguese population, 
namely: 
• Cognitive screening: Montreal Cognitive Assessment; 
• Processing speed: Symbol Search and Digit Symbol Subtests; 
• Attention: Toulouse-Piéron; 
• Subjective 
memory 
complaints: 
Subjective 
Memory 
Complaints 
Questionnaire (SMCQ); 
• Verbal memory: Auditory Verbal Learning Test (AVLT); 
• Visual memory: Rey-Complex Figure Test (RCFT) (3-minutes immediate recall 
trial); 
• Executive Functions: Verbal fluency tests (semantic and phonemic fluency), 
and RCFT (copy trial); 
• Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS) 
• Quality of Life: Quality of Life after Brain Injury (QOLIBRI); 
• Functional abilities: Adults and Older Adults Functional Assessment Inventory 
(IAFAI); 
• Motivation for the intervention: Motivation for Traumatic Brain Injury 
Rehabilitation Questionnaire (MOT-Q). 
 
 
 
 
 

Study protocol 
 
Informed consent 
I understand that all information derived from the study “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” is 
property of the responsible research team. I consent that the anonymous data about me 
(results, images, and videos properly anonymized) can be saved and processed for 
scientific evaluation. I understand the meaning of the information about the study, and 
my questions have been satisfactorily answered. I had enough time to decide on 
participation in this study. 
I hereby consent to my participation and the collection and use of information. 
I will receive a signed and dated copy of this informed consent. 
 
 
Participants’ signature  
…………………………………………………. 
Investigator 
…………………………………………………. 
 
Date: ___/___/___