Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)
Phase: NA
Conditions: Cognitive Dysfunction, Mild Cognitive Impairment
Sponsor: Badalona Serveis Assistencials

 
Research Project Protocol  
TITLE 
Development and evaluation of virtual reality experiences 
for cognitive stimulation at the El Carme Socio-Health 
Center in Badalona Healthcare Services (BSA) 
PROTOCOL CODE  
PI-23-195 
PROMOTER  
Badalona Assistance Services 
 
 
Principal investigators  
José Ferrer Costa (ORCID: 0000-0002-3789-6272) - MFiC, Innovation and projects. Badalona 
Assistance Services. Contact: jfcosta@bsa.cat  
Maria-José Ciudad (ORCID: 0000-0002-4431-7136), Neuropsychologist, CSSC, Badalona Serveis 
Assistencials, Spain  
Collaborating researchers  
José Luis Rodríguez García - Nurse, CSSC, Badalona Care Services.  
Maribel González Abad - TCAI, CSSC, Badalona Care Services.  
Victoria Escutia Pérez - TCAI, CSSC, Badalona Care Services. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 1 of 35 

 
SUBSTANTIAL MODIFICATIONS TO THE PROTOCOL  
Modification date  
Modified section  
Justification for the change 
31/07/2023  
CI - BSA Data 
Protection Officer 
contact added 
Assessed and approved by 
the BSA research 
committee, with the 
indication of this 
modification. 
23/09/2023  
Changes in the CI and in 
the patient information 
sheet: -New versions of 
the  
patient information 
sheet and the IC 
according to CEIC 
models. (annexes 1 
and 2.1)  
-Added the 
intervention 
information.  
-Added the CI version 
for a family member or 
legal representative 
(Annex 2.2) 
Clarifications requested 
by the CEIC 
23/09/2023  
Added to section 5.2  
Design the detailed  
explanation of the  
intervention. 
Clarifications requested 
by the CEIC 
23/09/2023  
Eliminated references to 
data will be coded so that 
the participants are not 
identified. 
Clarifications requested 
by the CEIC 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 2 of 35 

 
1. PROTOCOL SUMMARY  
Title and subtitles, version and 
date of the protocol 
Development and evaluation of virtual 
reality experiences for cognitive stimulation 
at the El Carme Socio-Health Center in 
Badalona Healthcare Services (BSA). 
Version 1.  
07/18/2023 
Name, surname of the main 
author and organization for which 
he or she works 
José Ferrer Costa (ORCID: 0000-0002-3789-6272) - 
MFiC, Innovation and projects. Badalona Assistance 
Services. Contact: jfcosta@bsa.cat 
 
 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 3 of 35 

 
1. BACKGROUND AND JUSTIFICATION  
The increasing prevalence of cognitive impairment and dementias, such as Alzheimer's disease, 
presents a significant challenge to global public health, with rapid intensification concomitant 
with population aging (United Nations, 2015). The impairment of memory, attention and 
executive functions that characterize these conditions substantially impacts the quality of life of 
patients, also exerting a considerable burden on caregivers and health systems.  
The term "dementia" encompasses various diseases and conditions that lead to a deterioration 
in memory, language, problem-solving abilities and other cognitive skills, consequently altering 
a person's ability to carry out activities of daily living. . This global problem affects more than 55 
million people, and adds around 10 million new cases annually (World Health Organization, 
2023). This constant increase calls for the design, implementation and evaluation of innovative 
therapeutic strategies to support the care and management of people with dementia and 
related conditions.  
The treatment of dementia is approached from several perspectives, including pharmacological 
and non-pharmacological interventions. While the former are aimed at managing the cognitive 
and non-cognitive symptoms of the disease, they do not provide a cure and can cause side 
effects. On the other hand, non-pharmacological interventions, such as cognitive rehabilitation 
programs, focus on training and improving cognitive abilities and teaching new strategies and 
skills to compensate for affected abilities. However, its effectiveness may be limited due to the 
difficulty of transferring learned skills to everyday contexts, given the artificiality of training 
environments.  
Healthy aging is a key goal for the world's rapidly aging population. As we look for ways to 
promote cognition and well-being in old age, technology-based interventions have become a 
popular approach. However, access to and effectiveness of these interventions can be affected 
by various barriers, such as unfamiliarity with or lack of access to the technology. According to a 
recent study by Zuschnegg et al. (2023), the results demonstrated that CCIs have a significant 
effect on memory, working memory, attention/concentration/processing speed and executive 
function in individuals with mild cognitive impairment, but no significant improvements were 
observed in global cognition and language. This study also highlighted the need for more 
research examining the effectiveness of these interventions in more realistic settings, such as 
participants' homes. This study aims to explore and evaluate the effectiveness of 
computer-based cognitive interventions (CCIs) in improving memory and cognition in 
community-dwelling older people, and analyze the barriers and facilitators to the use of CCIs, 
expanding thus the existing research.  
In this scenario, virtual reality (VR) has stood out as a powerful tool for cognitive stimulation in 
people with cognitive impairment. Its immersive and engaging nature allows it to provide an 
ecological, safe and controlled environment, in which users can practice cognitive and physical 
skills in digitally recreated everyday situations. Recent studies support the potential of VR to 
improve cognitive skills and reduce interference in individuals with mild cognitive impairment 
(MCI) (Goméz et al., 2022; Papaioannou et al., 2022; Chen et al., 2021; Bauer et al., 2022 al., 
2020). A recent meta-analysis and systematic review provides additional evidence by showing a 
positive impact of VR-based cognitive rehabilitation programs on cognitive and functional 
outcomes, including improvements in cognitive functions, daily functioning, depressive 
symptoms, and quality of life (Bitch A . et al., 2023).  
For the design of our project, the work of Muñoz et al. (2022) offers a solid foundation on 
which the “SWOT” matrix and general design guidelines for Human-Computer Interaction (HCI) 
are provided. These resources are useful to identify strengths, opportunities, weaknesses and 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 4 of 35 

 
threats of the use of virtual reality technology in cognitive rehabilitation and to optimize the 
usability of HCI in interventions that use this technology. Furthermore, a recent study 
conducted by Qiu et al. (2022) supports the acceptability and tolerance of a virtual 
reality-based cognitive training program in older adults, reflecting that the majority of 
participants found VR attractive and easy to use, without serious or severe adverse events.  
The main objective of this project is to carry out a pilot study to clinically evaluate the 
effectiveness of virtual reality (VR) sessions in a selected group of 20 patients from the El 
Carme Socio-Health Center in Badalona. These VR sessions will consist of 360-degree 
immersive experiences, designed and provided by Reality Telling, that will focus on recreating 
familiar environments and implementing memory and attention training exercises.  
The purpose of these sessions is twofold. On the one hand, we seek to validate the 
acceptability of these immersive experiences among patients and healthcare professionals, 
evaluating their willingness to adopt and interact with this innovative form of therapeutic 
intervention. On the other hand, we propose to examine the impact of immersive experiences 
in terms of improving cognitive performance, as well as on the commitment and motivation of 
patients towards their own cognitive rehabilitation process.  
2. BIBLIOGRAPHICAL REFERENCES  
Bauer, A. C. M., & Andringa, G. (2020). The potential of immersive virtual reality for cognitive 
training in elderly. Gerontology, 66(6), 614-623.  
Chen, P., Wei, S., Liu, X., & Liu, S. (2021). Effects of Virtual Reality-Based Cognitive and Physical 
Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild 
Cognitive Impairment: A Randomized Controlled Trial. Frontiers in Aging Neuroscience, 13, 
678484.  
Gómez-Cáceres B, Cano-López I, Aliño M, Puig-Perez S. Effectiveness of virtual reality-based 
neuropsychological interventions in improving cognitive functioning in patients with mild 
cognitive impairment: A systematic review and meta-analysis. Clin Neuropsychol. 2022 Nov 
23:1-34. doi: 10.1080/13854046.2022.2148283. Epub ahead of print. PMID: 36416175.  
Muñoz, J., Mehrabi, S., Li, Y., Basharat, A., Middleton, L. E., Cao, S., ... & Boger, J. (2022). 
Immersive virtual reality exergames for persons living with dementia: User-centered design 
study as a multistakeholder team during the COVID-19 pandemic. JMIR Serious Games, 10(1), 
e29987.  
United Nations Organization. (2015). World population aging. Department of Economic and 
Social Affairs, Population Division.  
 
https://www.un.org/en/development/desa/population/publications/pdf/ageing/WPA2015_Re 
port.pdf  
World Health Organization. (2023). Dementia, March 15, 2023. Facts and figures. 
https://www.who.int/es/news-room/fact-sheets/detail/dementia  
Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual 
Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A 
Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 
10.3233/JAD-210672. PMID: 35811514.  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 5 of 35 

 
Perra A, Riccardo CL, De Lorenzo V, De Marco E, Di Natale L, Kurotschka PK, Preti A, Carta MG. 
Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial 
Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of 
Published Effectiveness Studies. Int J Environ Res Public Health. 2023 Jan 14;20(2):1527. doi: 
10.3390/ijerph20021527. PMID: 36674283; PMCID: PMC9864668.  
Qiu R, Gu Y, Xie C, Wang Y, Sheng Y, Zhu J, Yue Y, Cao J. Virtual reality-based targeted cognitive 
training program for Chinese older adults: A feasibility study. Geriatr Nurs. 2022 
Sep-Oct;47:35-41. doi: 10.1016/j.gerinurse.2022.06.007. Epub 2022 Jul 12. PMID: 35839753.  
Zuschnegg J, Schoberer D, Häussl A, Herzog SA, Russegger S, Ploder K, Fellner M, 
Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schüssler S. 
Effectiveness of computer-based interventions for community-dwelling People with cognitive 
decline: a systematic review with meta-analyses. BMC Geriatr. 2023 Apr 12;23(1):229. doi: 
10.1186/s12877-023-03941-y. PMID: 37041494; PMCID: PMC10091663.  
3. HYPOTHESIS OR STUDY QUESTION  
Main Hypothesis:  
The application of a cognitive stimulation program with virtual reality will be well accepted by 
patients with mild cognitive impairment.  
Secondary Hypotheses:  
● Virtual reality interventions will be perceived as useful and motivating by patients, 
promoting positive adherence to the cognitive stimulation program.  
● Patients will improve their cognitive performance (attention and memory) on cognitive 
scales after the sessions.  
● Virtual reality interventions will be perceived as useful and applicable as a tool in the 
clinical practice of cognitive stimulation by healthcare professionals.  
4. GOALS  
4.1. Main objective  
 
To evaluate the acceptability of the cognitive stimulation program based on virtual reality 
among patients with mild or moderate cognitive impairment at the El Carme Socio-Health 
Center in Badalona.  
4.2. Goals specific  
To investigate whether VR interventions are perceived as useful and motivating by 
patients, which would translate into positive adherence to the cognitive stimulation 
program.  
Measure changes in cognitive performance (particularly in attention and memory) of 
patients before and after the VR intervention to evaluate the effectiveness of the cognitive 
stimulation program.  
Understand how healthcare professionals perceive VR interventions in terms of 
their applicability in the clinical practice of cognitive stimulation.  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 6 of 35 

 
Identify possible improvements in the implementation of the VR program based on the 
comments and suggestions of patients and healthcare personnel.  
Collect data and information that could be useful in developing future VR experiences 
for patients with cognitive impairment.  
5. RESEARCH METHODS  
5.1 Study type  
Type of study: Non-randomized prospective pilot study interventionist  
Study Description: This is an interventional study where an intervention not used in 
conventional practice will be evaluated, which consists of the use of virtual reality 
experiences for cognitive stimulation in patients with mild or moderate cognitive 
impairment. The VR experiences will be developed in collaboration with a technological 
partner, with the aim of potentially being incorporated into the cognitive rehabilitation 
program at the El Carme Socio-Health Center (CSSC) Day Hospital.  
5.2 Design  
This study will be prospective and non-randomized in design. Patients will be selected from 
among those who already attend cognitive rehabilitation sessions at the CSSC Day Hospital. 
There will be no control group in this pilot study, as the primary objective is to evaluate the 
usability and acceptability of the intervention.  
Experimental group: This group will be made up of 20 patients who attend cognitive 
rehabilitation sessions at the CSSC Day Hospital. These patients will participate in 8 
cognitive rehabilitation sessions that will incorporate the VR experiences developed for this 
study.  
Intervention  
Sessions:  
The 8 sessions will be held two days a week, at the time when the included participants 
have an appointment for the conventional cognitive rehabilitation program at the CSSC Day 
Hospital.  
Equipment and Technology:  
We use Oculus Quest 2 glasses and their hand tracking technology, which allows for a more 
immersive and less complicated experience for participants, especially those with MCI.  
Developed Virtual Reality Experiences:  
A) Interactive Cognitive Stimulation Exercises (Declarative Memory, Executive Functions):  
Developed jointly by the BSA VR and Reality Telling teams, following the researchers' 
guidelines, three types of sequential interactive exercises have been created:  
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 7 of 35 

 
Step 1- Make a Purchase at the Supermarket:  
● Scenario: Virtual supermarket.  
● Avatar: An animated avatar greets the participant and provides instructions.  
● Objective: Select ingredients to make a potato omelet or gazpacho.  
● Interaction: Participants use hand tracking technology to grab products and place them in 
a virtual cart.  
● Feedback: A success or error audio is emitted based on the product selection.  
Step 2- Pay for the Purchase:  
● Scenario: Checkout area of the virtual supermarket.  
● Avatar: An animated avatar greets the participant and provides instructions.  
● Objective: Pay the exact amount for the selected products.  
● Interaction: Select 3D models of bills and coins to reach the correct sum.  
● Feedback: An avatar and audio provide confirmation or correction.  
Step 3- Sort the Recipe Steps:  
● Scenario: Virtual kitchen.  
● Avatar: An animated avatar greets the participant and provides instructions.  
● Objective: Sort photos of the recipe steps.  
● Interaction: Drag and drop photos into a numbered panel.  
● Feedback: Confirmation of the avatar.  
Scenario details:  
- Step 1: Make a purchase at the supermarket. Upon entering the supermarket, an 
animated avatar greets the participant and explains that they must select the correct 
products to make a potato omelet or gazpacho. The products are arranged on a shelf, 
there are correct products and others incorrect. Participants must select by grabbing 
the products with their hand and taking them to the shopping cart. When you drop the 
products into the cart, the program recognizes them as correct or incorrect. If it is a 
correct product, an event audio plays and the product stays in the cart, if it is an 
incorrect one, an audio plays explaining that this product is incorrect, and the object 
automatically returns to the shelf.  
- Step 2: Pay for the purchase. In this exercise, the avatar explains that the ATM is not 
working and requests that they pay for the purchase with the exact value. We have 
created some 3D models of money and coins that are arranged next to the ATM. The 
value of money is added up on a screen as you select each of these models. If we go 
beyond the desired total, an audio plays explaining that we must try again, and the sum 
returns to zero. When the desired value is reached, it adds a congratulating audio.  
- Step 3: Order the steps of the recipe. In a kitchen, an animated avatar explains the 
exercise. We have before us some photos with the steps of the recipes for a tortilla or a 
gazpacho, and a box with 6 numbered spaces. The goal is to sort the photos of the 
steps, placing each of them in the numbered box in the correct order.  
B) Cognitive Stimulation with Videos (Attention and Episodic Memory):  
- Description of the Videos: 360-degree videos have been recorded in known environments 
in Badalona to maximize the familiarity and comfort of the participants, who are mostly 
residents of the area. The videos are of two types: static, where the perspective does 
not change; and in movement, which simulates a slow walk.  
- Real-time tracking technology: An application will be used that will allow the therapist to 
follow the video in real time on a tablet. This will facilitate the interaction between the 
therapist and the participant, improving the effectiveness of cognitive stimulation. - Video 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 8 of 35 

 
Listing:  
- Video 1 (6:24) “Plaça de la Vila Badalona”. Static video in front of the Badalona 
town hall.  
- Video 2 (5:00) “Carrer de Mar Badalona”. Motion video walking slowly along the 
main pedestrian street of Badalona  
- Video 3 (3:06) “Pas soterrani cap a la platja”. In motion walking slowly from the 
end of Calle de Mar to the beach.  
- Video 4 (2:00) “Walking along the Passeig Maritim Badalona - Part 1”. In motion 
walking at the beginning of the Passeig Marítim de Badalona.  
- Video 5 (2:00) “Walking along the Passeig Maritim Badalona - Part 2”. In motion 
walking along the Passeig Marítim.  
- Video 6 (3:30) “Walking along the Passeig Maritim Badalona - Part 3”. In motion 
walking along the Passeig Marítim from Anis del Mono to Pont del  
Petroli.  
- Video 7 (5:00) “You saw the Pont del Petroli Badalona”. Static on a balcony with 
views of the sea and the Pont del Petroli.  
- Video 8 (5:00) "Badalona Coconut Beach". Static on the Passeig Marítim.  
- Cognitive Stimulation Procedure with the videos:  
● Method: Visual-verbal stimulation in real time carried out by a researcher who 
accompanies the session.  
● Activity: While watching the videos, the researcher accompanying the session asks the 
participants to pay attention to specific elements, such as if they recognize the place, 
how many bicycles they have passed, if they have seen a dog, etc.  
● Interrogation:  
At the beginning of the session, the type of visualization to be carried out will be 
entered (“Next you will watch a video of a square in which you will see different scenes. 
Stay tuned.”).  
While viewing the scenes, you will be asked questions regarding the environment and 
the elements that appear to encourage attention. (“Do you recognize the square? Have 
you ever been? What is it called? What are you seeing? Pay close attention to all the 
details.”).  
At the end of each video, open and multiple choice questions will be asked. (“Have you 
seen any animals? How many dogs have you seen passing by, 2 or 5?…”) to evaluate 
attention and memory regarding the elements shown.  
● Objectives: The objective of this intervention is to stimulate and evaluate aspects of 
cognitive function such as attention (focused, sustained and alternating), memory and 
visuospatial function (immediate, working, episodic, semantic, spatial orientation, 
visual memory).  
● Participant Feedback: At the end of the session, feedback will be collected from 
participants to improve future interactions of the exercise.  
5.3 Participating population  
Source population: The source population of the study will be the patients who attend the 
cognitive rehabilitation program at the Centro Sociosanitario El Carme (CSSC) in Badalona 
Serviceis Asistencianals.  
Location: El Carme Socio-Health Center (CSSC), Badalona, Spain.  
Selection period: Participants will be selected from September to October 2023.  
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 9 of 35 

 
Inclusion criteria:  
− Participants must be at least 60 years old, with no maximum age limit.  
− Participants must be classified as having mild cognitive impairment with an MMSE score > 
23.  
− Participants must be currently attending cognitive rehabilitation sessions at the CSSC Day 
Hospital.  
− Participants must be able to give informed consent or, in the event of incapacity, consent 
must be obtained from their legal representative.  
− Exclusion criteria  
− Patients with a serious or unstable illness that may interfere with their participation in the 
study.  
− Patients with severe psychiatric disorders, such as psychotic disorders, delusions or 
hallucinations that may be exacerbated by the use of virtual reality.  
− Patients with severe visual limitations that would prevent the use of virtual reality.  
− The presence of eye diseases that cause blurred vision that cannot be corrected with contact 
lenses or glasses.  
− Presence of hearing pathologies that cause a significant decrease in hearing without hearing 
aids.  
− High sensitivity to motion sickness.  
− Epileptic subject.  
− Patients who are unable or unwilling to give informed consent.  
Withdrawal criteria  
Withdrawal criteria will include the appearance of health problems that may interfere with 
continued participation in the study, or withdrawal of consent by the participant.  
Sampling type  
The type of sampling will be non-probabilistic sequential. All patients who meet the 
inclusion criteria and do not meet any of the exclusion criteria will be invited to participate 
until the desired number of participants is reached.  
5.4 Study variables  
5.4.1 Variables result, exposure or effect  
Main Outcome Variable:  
Acceptability and usability of VR exercises: This will be measured using a user 
satisfaction questionnaire and the System Usability Scale (SUS). HE will managen after 
the last session (the eighth).  
Secondary Outcome Variables:  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 10 of 35 

 
Cognitive function (memory and attention), measured through standardized 
tests: - Specific to attention and memory (Digits, TMT [Annex 3], SDMT [Annex 4]).  
General cognitive function tests:  
- Montreal Cognitive Assessment (MoCA) [anexo 5]  
- Mini-Mental State Examination (MMSE) [anexo 6]  
The evaluations will be carried out before starting the training program and at the end 
of it (after the eighth session).  
Usability of the system by professionals:  
This will be evaluated using the System Usability Scale (SUS) for patients and 
professionals [Annex 7 and 8]. It will be administered to professionals after completing 
the training program.  
5.4.2 Other variables  
● Age  
● Sex  
● Etiology of cognitive impairment  
● Schooling  
● Exposure to other treatments: Any additional medication or cognitive therapy that the 
patient is simultaneously participating in will be recorded.  
5.5 Study Evaluations:  
Visit  
Procedures 
Selection visit (Pre-study) 
Informed consent, collection of demographic data and 
results of cognitive function variables 
Visit 1 (Session 1)  
Starting VR training sessions 
Visit 2 (Session 8 - Final) 
Completion of the VR training sessions, questionnaires 
on cognitive function and satisfaction and usability 
variables. 
 
 
5.6 Sample size  
The sample size for this pilot study has been established at 20 patients. This decision is 
based on several factors:  
Preliminary nature of the study: As this is a pilot study, the primary objective is to evaluate 
the usability and acceptability of the virtual reality intervention, rather than to 
demonstrate effectiveness. Pilot studies typically have smaller sample sizes than full 
studies.  
Resources and capacity: The capacity of the El Carme Socio-Health Center in Badalona and 
the available resources (both in terms of staff and virtual reality equipment) also influence 
the sample size. Ensuring that each participant can receive appropriate care and support is 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 11 of 35 

 
critical to accurate data collection and a positive patient experience.  
Patient variability: Although the sample size is small, it is expected to reflect the diversity of 
the patient population in terms of severity of cognitive impairment, gender, age, etc. This 
diversity may provide a deeper understanding of how different types of patients may 
interact with virtual reality technology.  
5.7 Statistical analysis  
The data collected during the study will be analyzed using statistical methods appropriate 
for each type of variable. All analyses will be performed using statistical software SPSS 
27.0.  
Acceptability and Usability: Scores obtained on the System Usability Scale (SUS) will be 
analyzed descriptively to provide an overall measure of the acceptability and usability of 
the VR intervention.  
Cognitive function: Depending on the normality of the variables, statistical tests will be 
applied to compare scores (parametric Student's T or non-parametric Wilcoxon (in the case 
of failure to comply with the assumption of normality).  
 
Demographic and clinical variables: Correlation and multiple regression analyzes will be 
used to examine relationships between demographic and clinical variables (e.g., age, 
gender, etiology, education) and changes in acceptability, usability, cognitive function, and 
quality of life. .  
The hypotheses will be evaluated at the significance level of p < 0.05 (95% confidence 
level). As this is a pilot study, the results will be used primarily to generate hypotheses for 
future research and to provide effect size estimates that may be useful for sample size 
calculation in future studies.  
5.8 Limitations  
1. Study design and sample size  
Limitation: The study is characterized by being a non-randomized pilot, without a control 
group, and of short duration. Likewise, it is carried out with a sample of 20 participants, 
which may limit its representativeness.  
Mitigation strategy: The preliminary nature of the study and the resources available at the 
El Carme Socio-Health Center in Badalona influence the decision to have a small sample 
size. The main objective is to evaluate the usability and acceptability of the VR intervention, 
rather than to demonstrate its effectiveness. Although the sample size is small, it is 
expected to reflect the diversity of the patient population, providing a deep understanding 
of how different types of patients may interact with VR. Furthermore, the results of the 
pilot study will provide crucial preliminary information for future larger and well-controlled 
investigations.  
2. Outcome measures  
Limitation: Measures of acceptability, usability, and cognitive function are largely 
self-reported, which may introduce bias.  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 12 of 35 

 
Mitigation strategy: Despite this limitation, the best available tests have been selected, 
recognizing that no test is perfect and that all have some limitations. In future research, we 
will seek to incorporate additional objective measures, if possible.  
3. Variability in VR exposure and effect of healthcare personnel  
Limitation: Individual experience with VR may vary due to factors such as degree of 
cognitive impairment, familiarity with the technology, and ability to follow instructions. 
Furthermore, the improvement in cognitive function could be influenced by the interaction 
with healthcare personnel during VR sessions.  
Mitigation strategy: An attempt will be made to standardize the administration of VR as 
much as possible and variables such as the duration and content of the interaction with 
healthcare personnel will be controlled.  
 
4. Training of health personnel  
 
Limitation: Healthcare personnel must be familiar with this technology for its effective 
implementation.  
Mitigation strategy: Extensive training and ongoing support will be offered to healthcare 
personnel. Additionally, it will be built on an existing VR application, designed specifically 
for the hospital environment.  
These limitations have been taken into account during the planning of the study and will be 
discussed in detail in the presentations and publications resulting from the study. Findings 
from the pilot study will be used to inform and improve the design of future research in this 
field.  
6. SOURCES OF OBTAINING AND MANAGING DATA  
6.1 Data source  
Data collection in this pilot study will be carried out through primary sources. Data will be 
obtained directly from participants:  
The acceptability and usability of the VR exercises will be measured through questionnaires 
that participants will complete after each VR session.  
Cognitive function and quality of life will be measured through standardized tests that 
participants will complete before, during and after the VR training program.  
Variables such as age, gender and degree of cognitive impairment will be collected through 
interviews and medical records.  
Exposure to other treatments will be recorded through interviews with participants and 
review of their medical records.  
6.2 Data management and quality control  
Data recording will be carried out using standardized spreadsheet templates to ensure 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 13 of 35 

 
consistency in data collection. The data of each participant will be registered using a unique 
identification code for each participant to maintain confidentiality.  
To ensure data security, data will be stored in a secure folder within the BSA intranet. This 
folder will have restricted access to the main investigators of the study to maintain the 
privacy of the data and avoid unauthorized manipulations.  
Finally, before analyzing the data, it will be cleaned and reviewed to detect and correct any 
inconsistencies or errors. This stage will ensure that the results of the statistical analysis are 
based on accurate and valid data.  
7. PROTECTION OF PERSONS UNDER INVESTIGATION  
 
7.1 Benefit-risk evaluation for research subjects  
This interventional study uses virtual reality (VR) for cognitive stimulation of patients with 
cognitive impairment. The following potential risks and benefits to participants have been 
identified, along with specific mitigation strategies for the identified risks.  
Risks and Mitigation Strategies:  
1- Side effects of VR: Some patients may experience dizziness or disorientation with VR. To 
mitigate this risk, static or smooth motion VR experiences will be designed, and the 
technology will be introduced gradually. Side effects will be carefully monitored, especially 
in patients with conditions that may increase risk.  
2- Patient acceptance: Since VR is a relatively new technology, it can be intimidating for 
some patients. To overcome this barrier, the potential benefits of VR will be effectively 
communicated and patient concerns will be proactively managed. Engagement with 
healthcare personnel during the process can improve patient acceptance and adherence.  
3- Technical problems: Like any technology, VR can face technical problems such as 
hardware or software failures, or Internet connectivity problems. To mitigate this risk, 
backup equipment will be available and appropriate training will be provided to healthcare 
personnel to handle VR equipment. Fast and efficient technical support will also be 
guaranteed to resolve any issues that may arise.  
4- Technical problems: Like any technology, VR can face technical problems such as 
hardware or software failures, or Internet connectivity problems. To mitigate this risk, 
backup equipment will be available and appropriate training will be provided to healthcare 
personnel to handle VR equipment. Fast and efficient technical support will also be 
guaranteed to resolve any issues that may arise.  
5- Exclusion of certain patients: Some patients may not be able to participate due to severe 
cognitive impairment, dizziness, certain visual impairments or other health conditions, 
which could potentially lead to feelings of exclusion or frustration. To mitigate this risk, 
communication with patients about the limitations of who can participate in the study will 
be clear, explaining health and safety reasons. For those patients who are unable to 
participate, other alternative activities or interventions will be explored.  
6- Physical safety: There is a risk of patients tripping or falling while using VR due to spatial 
disorientation. To mitigate this risk, patients will be seated during VR sessions and will be 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 14 of 35 

 
closely supervised by healthcare personnel to ensure their safety. Additionally, the area 
around the patient will be free of obstacles.  
7- Withdrawal effect: If the VR tool is withdrawn after the conclusion of the study, the 
patients who participated may show less interest in continuing with the conventional 
cognitive stimulation program. To mitigate this risk, if the results of the study are positive 
and show significant benefits for patients, a commitment will be made to keep this tool in 
use within the cognitive stimulation program.  
 
Benefits  
1- Cognitive stimulation: VR offers an interactive and attractive medium for cognitive 
stimulation, which can be more motivating and attractive for patients than traditional 
therapies.  
2- Improved emotional well-being: Patients may experience an improvement in their 
emotional well-being when participating in immersive VR experiences, especially if the 
sessions are designed to be enjoyable and fun.  
3- Contribution to research: Patients will participate in a study that may contribute to 
improving the understanding and treatment of cognitive impairment.  
To ensure the safety and comfort of participants, healthcare personnel will receive 
extensive training in the use of VR. All necessary precautions will be taken to minimize risks 
and participants will be closely monitored for any side effects. It is hoped that participation 
in the study can have a positive impact on the cognition and emotional well-being of the 
participants, and that it contributes to research in this field.  
7.2 Information to subjects and informed consent  
The research team is committed to ensuring that all potential participants receive clear, 
complete and understandable information about the study. This information will include 
details about the purpose of the research, the procedures that will be carried out, the 
possible benefits and risks, and the management of the confidentiality of personal 
information and the results of the study.  
To achieve this goal, the following methods will be used:  
Informed Consent Document: An Informed Consent document has been developed and will 
be provided to each potential participant. This document will include detailed information 
about the study, including the purpose, procedures, possible risks and benefits. The 
document will also emphasize that participation in the study is completely voluntary, and 
that the individual has the right to withdraw from the study at any time without 
repercussions on his or her medical care.  
Information Sheet for Participants: Potential participants will be provided with an 
Information Sheet, which will complement the Informed Consent document, offering a 
summary of key study information in an easy-to-understand format.  
Information Sessions: During meetings with potential participants, they will be given the 
opportunity to ask questions and discuss any concerns they may have. Before obtaining 
consent, it will be verified that the participant has fully understood the information 
provided. To facilitate understanding, all aspects of the study will be explained using simple 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 15 of 35 

 
and accessible language.  
Consent of Legal Representatives: In cases of patients with moderate cognitive impairment 
who may have difficulties understanding the information provided or giving their consent, 
informed consent will be requested from their legal representative. The legal 
representative will be present during the explanation of the information and obtaining 
consent.  
The principle of autonomy of the participants will be respected at all times. No individual 
will be included in the study without having provided valid informed consent, either 
directly or through their legal representative. A record of the consent process will be 
maintained for each participant to ensure transparency and accountability.  
7.3 Confidentiality and data protection  
This study fully complies with Spanish and European data protection regulations, including 
Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of 
digital rights, as well as Regulation (EU) 2016/679 of the European Parliament and of the 
Council of 27 April 2016 on the protection of natural persons with regard to the processing 
of personal data and the free circulation of such data.  
Origin of data: Data will be obtained both directly from patients through questionnaires 
and evaluations, and from their medical records to collect demographic and clinical data.  
Consent for data processing: Informed consent will be obtained from all patients for the 
processing of their data. Additionally, we will keep this data pseudonymized to protect the 
identity of patients.  
External promoter with access to data: There is no external promoter with access to data. 
Only the principal investigators of the study will have access to the full data.  
Collaboration with companies: We work in collaboration with the company Reality Telling, 
however, the results of the study will only be shared with them after being analyzed and 
without personal data that allows the participants to be identified. In no case will raw data 
be shared directly from participants or any personal data that may identify them.  
Data storage location and IT tools: Data will be stored securely within the BSA intranet. The 
computer tools we use to manage and analyze data are secure and have been approved by 
the Information Systems Department.  
Security measures: We have implemented rigorous security measures, including access 
codes and passwords, to ensure that only members of the research team have access to 
the data.  
International Data Transfers: No international data transfers are planned.  
High-risk treatments: High-risk treatments are not foreseen, such as data profiling 
techniques, automated decision making, artificial intelligence, data exploitation with Big 
Data technologies, biometrics or geolocation systems. All data will be used exclusively for 
the purposes of this study and will be handled in accordance with applicable data 
protection regulations..  
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 16 of 35 

 
8. MANAGEMENT AND COMMUNICATION OF ADVERSE REACTIONS  
As this study uses virtual reality in cognitive stimulation for patients with cognitive 
impairment and does not involve the use of medications, the management and 
communication of adverse drug reactions is not applicable in this context.  
However, any adverse side effects associated with the use of virtual reality technology, such 
as dizziness, nausea or disorientation, will be carefully recorded and monitored by the 
research team. Healthcare professionals are trained to handle these incidents and will 
provide necessary care to study participants should these adverse effects occur.  
The research team agrees to inform the collaborating company, Reality Telling, about any 
incident that occurs during the study, respecting the confidentiality of the participants. In 
the event of a serious adverse reaction, the research team will take necessary steps to 
ensure the safety of the participant and determine whether their participation in the study 
needs to be adjusted or discontinued.  
9. DISSEMINATION AND COMMUNICATION PLANS OF RESULTS  
Our goal is to share the findings of this study on the use of virtual reality in cognitive 
decline with the scientific and medical community. Consequently, we intend to try to 
publish the results of this study in a peer-reviewed scientific journal and, to the extent 
possible, present them at a relevant conference or conference in the field. While we cannot 
guarantee acceptance on such platforms, we are committed to transparency and ethics, 
and we we will strive for making our findings widely accessible.  
10. SOURCE OF FINANCING  
This study benefits from a grant from the AMB, which is intended for the creation of digital 
content from Reality Telling, the company in charge of developing the virtual reality 
program. As recipients of this scholarship, Reality Telling assumes the responsibility of 
coordinating the procurement of all hardware equipment necessary for the sessions. This 
includes organizing and securing resources to obtain virtual reality glasses, tablets, bags, 
modems and SIM cards for Internet connection, if necessary.  
In addition, Reality Telling guarantees the necessary training for the efficient use of these 
technological tools in the context of research. This support eliminates any significant 
additional costs associated with the development and implementation of the virtual reality 
program.  
BSA professionals, within the framework of their regular responsibilities, will conduct the 
investigation. While this involves time commitment to study design, data collection and 
analysis, and preparation of results for publication, these costs are part of BSA's regular 
operations and do not require additional funding.  
Additional costs may be associated with publishing study results. Should these arise, we 
will seek additional funding through other available scholarships or grants. If such financing 
is not obtained, these costs will be assumed by BSA. In this way, we ensure that both the 
financing and the resources necessary to carry out and disseminate the study are duly 
guaranteed.  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 17 of 35 

 
11. WORK PLAN FOR CONDUCTING THE STUDY  
Phase 1 (July-September 2023): Definition and validation of the beneficiaries, formulation 
of the study protocol and initial development of the VR exercises.  
Milestone 1: Formulation of the study protocol, assessment and approval by the BSA 
research committees and the GTP CEIC (July-September 2023)  
Milestone 2: Start of development of VR exercises (July-August 2023)  
Phase 2 (September-November 2023): Completion of the development of the VR 
exercises, recruitment of patients who will participate in the study and training of the CSSC 
Day Hospital staff for the implementation of the immersive VR experiences. Preparation 
for the start of data collection.  
Milestone 3: Completion of the development of VR exercises (September-October 
2023) Milestone 4: Patient recruitment (September-October 2023)  
Milestone 5: Training of Day Hospital staff for the implementation of immersive VR 
experiences (September-October 2023)  
Milestone 6: Preparation for the start of data collection (November 2023)  
Milestone 7: Start of data collection: November 2023  
Phase 3 (November-December 2023): Implementation of the pilot study with selected 
patients and data collection. Completion of data collection at the end of this period. 
Milestone 8: Start of the pilot study (November 2023)  
Milestone 9: Completion of the pilot study and data collection (December 2023)  
End of data collection: December 2023 - January 2024  
Interim reports of results (if applicable): Not applicable in this study due to its 
short duration.  
Final report: January 2024  
Milestone 10: Preparation of the final report (January 2024)  
Milestone 11: Presentation of the final report that includes the results of the pilot 
study, analysis of the data collected, conclusions and recommendations for future 
research or implementations based on VR experiences (January 2024)  
 
Phase  
Milestone  
Chronology 
Phase 1 
Milestone 1: Formulation of the study 
protocol, assessment and approval by the 
BSA research committees and the GTP 
CEIC 
July-Septem
ber 2023 
August-September 
2023 
Milestone 2: Start of development of 
VR exercises  
July-August 
2023 
Phase 2: 
Milestone 3: Completion of VR 
exercises development 
September  
October 2023 
 
 
  
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 18 of 35 

 
September-Novem
ber 2023  
Milestone 4: Patient recruitment 
September  
October 2023 
 
Milestone 5: Training of Day Hospital staff for 
the implementation of immersive VR 
experiences 
September  
October 2023 
 
Milestone 6: Preparation for the start of 
data collection  
November 2023 
 
Milestone 7: Start of data collection  
November 2023 
Phase 3:  
Milestone 8: Start of the pilot study  
November 2023 
November-Decem
ber 2023 
Milestone 9: Completion of the pilot study 
and data collection 
December 
2023- January 
2024 
Final Report:  
Milestone 10: Preparation of the final report  
January 2024 
January 2024  
Milestone 11: Presentation of the final report  
January 2024 
 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 19 of 35 

 
ANNEX 1. Patient information sheet  
PATIENT INFORMATION SHEET AND INFORMED CONSENT TO PARTICIPATE IN A RESEARCH 
PROJECT  
 
Project Title: Development and evaluation of virtual reality experiences for cognitive 
stimulation at the El Carme Socio-Health Center in Badalona Servicios Asistenciales 
(BSA)  
PROMOTER  
Badalona Assistance Services (BSA) 
Protocol Code  
PI-23-195 
 
 
PRINCIPAL INVESTIGATOR  
Jose Ferrer Costa 
CONTACT PHONE  
+34 937407482 
 
 
 
CENTER  
Badalona Assistance Services 
SERVICE  
Innovation and Projects 
CENTER ADDRESS  
C/ Via Augusta, 9-13 
POPULATION  
Badalona  
CP  
08911  
PROVINCE  
Barcelona 
 
 
We are writing to you to inform you about a research study that is being carried out at 
Badalona Serveis Assistencials (BSA) in which we invite you to participate. This project 
focuses on evaluating the potential of virtual reality (VR) experiences as a cognitive 
stimulation tool for people with mild or moderate cognitive impairment. This study is 
approved by the Research Ethics Committee. Our intention is that you receive correct 
and sufficient information to accept or not participate in this study. Therefore, read this 
document carefully and we will clarify any doubts that may arise.  
Voluntary participation  
You should know that your participation in this study is voluntary and that you may 
decide NOT to participate. If you decide to participate, you can change your decision 
and withdraw consent at any time, without altering your relationship with your doctor or 
causing any harm to your medical care.  
Objective of the Study  
Main Objective:  
We want to know if the cognitive stimulation program with Virtual Reality is well 
accepted by patients with mild or moderate cognitive impairment.  
Specific Objectives:  
Is it Useful and Motivating?  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 20 of 35 

 
We are interested in knowing if the VR activities are useful to you and if they motivate 
you to continue participating in the program.  
Does it improve your Cognition?  
We will measure how certain mental skills, such as attention and memory, change 
before and after using the VR program.  
Professional Opinion:  
We want to understand what healthcare professionals think about using VR in their 
daily work with patients like you.  
How can we improve?  
 
Your opinion and that of the medical staff will help us improve the program for future 
patients.  
Basis for Future Studies:  
The data we collect could help develop better VR programs in the future.  
Study Description  
Various research has shown that VR can be effective in improving cognitive abilities. 
This study seeks to investigate how personalization of VR experiences can increase 
the effectiveness of these interventions.  
This intervention program offers 8 cognitive rehabilitation sessions through Virtual 
Reality, which will take place twice a week in accordance with your regular 
appointments at the CSSC Day Hospital. For the intervention, the Oculus Quest 2 
glasses will be used, providing a more immersive experience.  
Study activities. What does your participation entail?:  
The study activities are divided into interactive exercises and immersive videos using 
virtual reality glasses.  
Below we describe the exercises that will be carried out:  
Interactive exercises in virtual reality:  
Step 1: Make a Supermarket Purchase: You will select ingredients to make a recipe in 
a virtual supermarket. An animated avatar will guide you.  
Step 2: Pay for the Purchase: You will have to pay the exact amount for the products 
selected in the virtual checkout.  
Step 3: Sort the Recipe Steps: You will need to sort photos of the recipe steps in a 
virtual kitchen.  
Note: During these exercises, you will always be accompanied by a therapist to ensure 
your safety and guide you through the activities.  
Cognitive Stimulation with Immersive Videos:  
360-degree videos have been recorded in familiar environments in Badalona to 
maximize the familiarity and comfort of the participants. The videos are of two types: 
static, where the perspective does not change; and in movement, which simulates a 
slow walk.  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 21 of 35 

 
A therapist will interact with you in real time through an application to guide attention 
and memory exercise.  
Participation in this study will not entail any change in your treatment or the rest of your 
medical treatment.  
Your participation will involve recording it in your medical history and recording scales 
and questionnaires that you must complete with one of the study professionals to 
assess the results.  
 
Risks and Preventive Measures  
Although the risks associated with VR use are generally low, some patients may 
experience dizziness or disorientation. However, we have implemented measures to 
minimize these risks, including designing VR experiences with smooth movements and 
gradually introducing the technology.  
Possible Benefits  
It is essential that you understand that your participation in this study does not 
guarantee direct benefits to your health. Our primary purpose is to investigate and gain 
a greater understanding of the potential of virtual reality experiences in cognitive 
stimulation for people with mild to moderate cognitive impairment.  
However, participating in this study has some additional advantages that could be 
considered indirect benefits:  
● Learning New Technologies: You will have the opportunity to become familiar with 
the innovative technology of Virtual Reality, a tool that is increasingly being used 
in the field of healthcare.  
● Cognitive Stimulation: Although we cannot guarantee specific results, it is 
expected that the use of VR can enhance the effects of cognitive rehabilitation, 
improving areas such as memory and attention.  
● Rewarding Experience: VR sessions are gamified, that is, they have a game 
format, which could result in a personally rewarding experience and a time of 
distraction and entertainment.  
Finally, it is important to note that although we are evaluating new interventions, we 
cannot anticipate the specific medical benefits of these. However, the data we collect 
could be very useful to improve the care of future patients with similar conditions.  
Expenses and Economic Compensation  
Your participation in this study will not involve any additional costs for you. You will not 
receive any financial compensation for participating in the study.  
Who finances the study?  
This study has external funding received by a scholarship. However, we want to assure 
you that this does not affect the integrity or objectives of the study.  
Confidentiality and Data Protection  
In accordance with articles 6.1.a and 9.2.a of Regulation (EU) 2016/679 of the 
European Parliament and of the Council, of April 27, 2016, regarding the protection of 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 22 of 35 

 
natural persons with regard to the processing of personal data and the free circulation 
of this data (GDPR), we need your consent to use your health data within the 
framework of this research project. The data will be kept in accordance with applicable 
legislation and as long as it is necessary for the development of this project.  
 
The processing of your data will be carried out in compliance with the RGPD and 
Organic Law 3/2018, on Data Protection and Guarantee of Digital Rights (LOPD-GDD). 
Therefore, you have the right to exercise your rights of access, rectification, deletion, 
opposition, limitation of processing and data portability, in front of the Catalan Institute 
of Health, with NIF Q-5855029-Y and address in Gran Via de les Corts Catalanes 587, 
Barcelona, through the main researcher of the project. You can contact the BSA Data 
Protection Officer via dpd@bsa.cat.  
We inform you that you have the right to withdraw your consent for the processing of 
this data at any time, by communicating this to the principal investigator. You also have 
the right to file a claim with the Catalan Data Protection Authority if you consider that 
your rights have been violated.  
No communications of data to third parties are foreseen, beyond those legally 
established, nor are international data transfers foreseen.  
We will collect data before and after the sessions to evaluate the effectiveness of the 
VR experiences. This data will include measures of your cognitive performance, as well 
as your impressions and experiences with VR. All data collected will be treated with the 
utmost confidentiality and will only be used for scientific purposes, to validate our 
hypotheses and improve this potential therapeutic tool.  
Informed Consent  
Before participating, you will need to sign an Informed Consent document that explains 
the study in detail.  
Contact in case of doubts  
If you have any questions or require more information, please do not hesitate to 
contact our research team.  
Research Team: jfcosta@bsa.cat, +34 937407482  
BSA Data Protection Officer: dpd@bsa.cat, Tel. 93 253 18 20  
We appreciate your consideration and look forward to your participation in this 
important study.  
Sincerely,  
The BSA research team.  
Additional documentation: A copy of this document and the signed Informed Consent will be provided 
for your reference.  
 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 23 of 35 

 
ANNEX 2.1. Informed consent form for the patient  
Informed Consent (IC) Sheet  
Project Title: Development and evaluation of virtual reality experiences for cognitive 
stimulation at the El Carme Socio-Health Center in Badalona Servicios Asistenciales 
(BSA)  
PROMOTER  
Badalona Assistance Services (BSA) 
Protocol Code  
PI-23-195 
 
 
PRINCIPAL INVESTIGATOR  
Jose Ferrer Costa 
CONTACT PHONE  
+34 937407482 
 
 
 
CENTER  
Badalona Assistance Services 
SERVICE  
Innovation and Projects 
CENTER ADDRESS  
C/ Via Augusta, 9-13 
POPULATION  
Badalona  
CP  
08911  
PROVINCE  
Barcelona 
 
 (Name and surname) 
 
I have read the information sheet that has been given to me.  
I have been able to ask about the study.  
I have received sufficient information about the study.  
I have spoken with: , .  
I understand that my participation is voluntary.  
I understand that I can withdraw from the study:  
1st whenever  
2nd without having to give explanations  
3rd without this affecting my medical care.  
I freely give my consent to participate in the study.  
Patient signature ​
​
​
​
​
Investigator's signature  
Date: ​
​
​
​
​
​
​
Date:  
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 24 of 35 

 
ANNEX 2.2. Informed consent sheet for the family member or legal representative  
Informed Consent (IC) Sheet  
Project Title: Development and evaluation of virtual reality experiences for cognitive 
stimulation at the El Carme Socio-Health Center in Badalona Servicios Asistenciales BSA)  
PROMOTER  
Badalona Assistance Services (BSA) 
Protocol Code  
PI-23-195 
 
PRINCIPAL INVESTIGATOR  
Jose Ferrer Costa 
CONTACT PHONE  
+34 937407482 
 
 
CENTER  
Badalona Assistance Services 
SERVICE  
Innovation and Projects 
CENTER ADDRESS  
C/ Via Augusta, 9-13 
POPULATION  
Badalona  
CP  
08911  
PROVINCE  
Barcelona 
 
(Name and surname of the representative) 
 
I declare under my responsibility that:  
(Name and surname of the patient)  
I have read the information sheet that has been given to me.  
I have been able to ask about the study.  
I have received sufficient information about the study.  
I have spoken with: , .  
I understand that your participation is voluntary.  
I understand that you can withdraw from the study:  
1st whenever  
2nd without having to give explanations  
3º without this affecting your medical care.  
I freely give my consent to participate in the study.  
Signature of representative ​ ​
​
Investigator's signature  
 
Date:  
Date: 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 25 of 35 

 
ANNEX 3. Attention and memory test: TMT  
 
Trail Making Test (TMT) Parts A & B  
 
 
Instructions:  
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part  A, 
the circles are numbered 1 – 25, and the patient should draw lines to connect the numbers in  
ascending order. In Part B, the circles include both numbers (1 – 13) and letters (A – L); as in  Part A, 
the patient draws lines to connect the circles in an ascending pattern, but with the added  task of 
alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should  be instructed 
to connect the circles as quickly as possible, without lifting the pen or pencil from  the paper. Time the 
patient as he or she connects the "trail." If the patient makes an error, point  it out immediately and 
allow the patient to correct it. Errors affect the patient's score only in that  the correction of errors is 
included in the completion time for the task. It is unnecessary to  continue the test if the patient has 
not completed both parts after five minutes have elapsed.   
Step 1: Give the patient a copy of the Trail Making Test Part A worksheet and a pen or  pencil.   
Step 2: Demonstrate the test to the patient using the sample sheet (Trail Making Part A –  SAMPLE).   
Step 3: Time the patient as he or she follows the “trail” made by the numbers on the test.  Step 4: 
Record the time.   
Step 5: Repeat the procedure for Trail Making Test Part B.   
Scoring:  
Results for both TMT A and B are reported as the number of seconds required to complete the  task; 
therefore, higher scores reveal greater impairment.   
 Average Deficient Rule of Thumb  Trail A 29 seconds > 78 seconds Most in 90 seconds  Trail B 
75 seconds > 273 seconds Most in 3 minutes   
Sources:  
• Corrigan JD, Hinkeldey MS. Relationships between parts A and B of the Trail Making Test. J  Clin 
Psychol. 1987;43(4):402–409.   
• Gaudino EA, Geisler MW, Squires NK. Construct validity in the Trail Making Test: what  makes 
Part B harder? J Clin Exp Neuropsychol. 1995;17(4):529-535.   
• Lezak MD, Howieson DB, Loring DW. Neuropsychological Assessment. 4th ed. New York:  Oxford 
University Press; 2004.   
• Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Percept  Mot 
Skills. 1958;8:271-276.  
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 26 of 35 

 
Trail Making Test Part A  
 
Patient’s Name: Date: 
 
 
Trail Making Test Part A – SAMPLE 
 
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 27 of 35 

 
 
Trail Making Test Part B  
 
Patient’s Name: Date:  
 
 
Trail Making Test Part B – SAMPLE 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 28 of 35 

 
 
ANNEX 4. Attention and memory test: SDMT  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 29 of 35 

 
ANEXO 5. Montreal Cognitive Assessment (MoCA)  
 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 30 of 35 

 
ANEXO 6. Mini-Mental State Examination (MMSE)  
 
Mini-Mental State Examination (MMSE)  
 
Patient’s code: ​ ​
​
​
Date:   
Instructions: Ask the questions in the order listed. Score one point for 
each correct  response within each question or activity.   
Maximum  
Score  
Patient’s  
Score  
Questions  
5  
 
“What is the year? Season? Date? Day of the week? Month?”  
5  
 
“Where are we now: State? County? Town/city? Hospital? Floor?”  
3  
 
The examiner names three unrelated objects clearly and slowly, 
then  asks the patient to name all three of them. The patient’s 
response is  used for scoring. The examiner repeats them until 
patient learns all of  them, if possible. Number of trials: 
___________ 
5  
 
“I would like you to count backward from 100 by sevens.” (93, 86, 
79,  72, 65, …) Stop after five answers.   
Alternative: “Spell WORLD backwards.” (D-L-R-O-W)  
3  
 
“Earlier I told you the names of three things. Can you tell me what 
those  were?”  
2  
 
Show the patient two simple objects, such as a wristwatch and a 
pencil,  and ask the patient to name them.  
1  
 
“Repeat the phrase: ‘No ifs, ands, or buts.’”  
3  
 
“Take the paper in your right hand, fold it in half, and put it on the 
floor.”  (The examiner gives the patient a piece of blank paper.)  
1  
 
“Please read this and do what it says.” (Written instruction is 
“Close  your eyes.”)  
1  
 
“Make up and write a sentence about anything.” (This sentence 
must  contain a noun and a verb.)  
1  
 
“Please copy this picture.” (The examiner gives the patient a 
blank  piece of paper and asks him/her to draw the symbol 
below. All 10  angles must be present and two must intersect.)  
30  
 
TOTAL  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 31 of 35 

 
 
 
(Adapted from Rovner & Folstein, 1987)  
1  
Source: www.medicine.uiowa.edu/igec/tools/cognitive/MMSE.pdf Provided by NHCQF, 0106-410 
Instructions for administration and scoring of the MMSE  
Orientation (10 points):   
• Ask for the date. Then specifically ask for parts omitted (e.g., "Can you also tell me 
what season it  is?"). One point for each correct answer.   
• Ask in turn, "Can you tell me the name of this hospital (town, county, etc.)?" One 
point for each  correct answer.   
Registration (3 points):  
• Say the names of three unrelated objects clearly and slowly, allowing approximately one 
second for  each. After you have said all three, ask the patient to repeat them. The 
number of objects the  patient names correctly upon the first repetition determines the 
score (0-3). If the patient does not  repeat all three objects the first time, continue 
saying the names until the patient is able to repeat all  three items, up to six trials. 
Record the number of trials it takes for the patient to learn the words. If  the patient 
does not eventually learn all three, recall cannot be meaningfully tested.   
• After completing this task, tell the patient, "Try to remember the words, as I will ask for 
them in a  little while."   
Attention and Calculation (5 points):  
• Ask the patient to begin with 100 and count backward by sevens. Stop after five 
subtractions (93,  86, 79, 72, 65). Score the total number of correct answers.   
• If the patient cannot or will not perform the subtraction task, ask the patient to spell the 
word "world"  backwards. The score is the number of letters in correct order (e.g., 
dlrow=5, dlorw=3).   
Recall (3 points):  
• Ask the patient if he or she can recall the three words you previously asked 
him or her to  remember. Score the total number of correct answers (0-3).   
Language and Praxis (9 points):  
• Naming: Show the patient a wrist watch and ask the patient what it is. Repeat with a 
pencil. Score  one point for each correct naming (0-2).   
• Repetition: Ask the patient to repeat the sentence after you ("No ifs, ands, or buts."). 
Allow only one  trial. Score 0 or 1.   
• 3-Stage Command: Give the patient a piece of blank paper and say, "Take this paper in 
your right  hand, fold it in half, and put it on the floor." Score one point for each part of 
the command correctly  executed.   
• Reading: On a blank piece of paper print the sentence, "Close your eyes," in letters 
large enough  for the patient to see clearly. Ask the patient to read the sentence and 
do what it says. Score one  point only if the patient actually closes his or her eyes. 
This is not a test of memory, so you may  prompt the patient to "do what it says" 
after the patient reads the sentence.   
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 32 of 35 

 
• Writing: Give the patient a blank piece of paper and ask him or her to write a sentence 
for you. Do  not dictate a sentence; it should be written spontaneously. The sentence 
must contain a subject  and a verb and make sense. Correct grammar and 
punctuation are not necessary.   
• Copying: Show the patient the picture of two intersecting pentagons and ask the patient 
to copy the  figure exactly as it is. All ten angles must be present and two must 
intersect to score one point.  Ignore tremor and rotation.   
(Folstein, Folstein & McHugh, 1975)  
2  
Source: www.medicine.uiowa.edu/igec/tools/cognitive/MMSE.pdf Provided by NHCQF, 0106-410 
Interpretation of the MMSE  
Method  
Score  
Interpretation  
Single Cutoff  
<24  
Abnormal  
Range  
<21   
>25  
Increased odds of dementia   
Decreased odds of dementia  
Education  
21   
<23   
<24  
Abnormal for 8th grade education   
Abnormal for high school education   
Abnormal for college education  
Severity  
24-30   
18-23   
0-17  
No cognitive impairment   
Mild cognitive impairment   
Severe cognitive impairment  
 
Sources:   
• Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the 
mini-mental state  examination by age and educational level. JAMA. 
1993;269(18):2386-2391.   
• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the 
cognitive state  of patients for the clinician. J Psychiatr Res. 1975;12:189-198.   
• Rovner BW, Folstein MF. Mini-mental state exam in clinical practice. Hosp Pract. 
1987;22(1A):99, 103, 106,  110.   
• Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am 
Geriatr Soc.  1992;40(9):922-935.    
Source: www.medicine.uiowa.edu/igec/tools/cognitive/MMSE.pdf Provided by NHCQF, 0106-410 
 
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 33 of 35 

 
 
ANNEX 7. System Usability Scale (SUS) for patients  
System Usability Scale (SUS) for patients 
 
 
 
 
 
Simulation assessment - System usability scale  
Strongly  
disagree 
little  
disagree 
Neutral  
little  
agree 
I quite 
agree 
1 I think I would like to use this program frequently 
 
 
 
 
 
2 I think the program is too complex 
 
 
 
 
 
3 I think that exercises with glasses are more entertaining 
than in a conventional way 
 
 
 
 
 
4 I think the simulation options are clear and well 
integrated  
5 I think some options are difficult to follow  
6 I think people will be able to learn how to use this system 
easily  
7 I felt comfortable using this system 
 
 
 
 
 
8 I had to learn many things before I could use the system 
 
 
 
 
 
VR headset rating - Quest 2  
Strongly  
disagree 
little  
disagree 
Neutral  
little  
agree 
I quite 
agree 
1 The glasses were very heavy and  
uncomfortable 
 
 
 
 
 
2 The use of glasses and controls has been very complicated 
 
 
 
 
 
3 I have felt tiredness in my arms and fingers 
 
 
 
 
 
4 I have felt visual discomfort 
 
 
 
 
 
5 I have felt dizzy 
 
 
 
 
 
6 I have felt a headache 
 
 
 
 
 
7 I had to stop the simulation due to the 
aforementioned discomfort 
 
 
 
 
 
8 I think it would be comfortable to wear these glasses for a 
long time 
 
 
 
 
 
 
COMMENTS:  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 34 of 35 

 
ANNEX 8. System Usability Scale (SUS) for professionals  
System Usability Scale (SUS) for professionals 
 
 
 
 
 
Simulation assessment - System usability scale  
Strongly  
disagree 
little  
disagree 
Neutral  
little  
agree 
I quite 
agree 
1 I believe this program will help improve the quality of 
patient care. 
 
 
 
 
 
2 I think the program interface is intuitive for the user. 
 
 
 
 
 
3 I believe that the program can be easily integrated 
into daily care practice. 
 
 
 
 
 
4 I believe that the functions and features of simulation are 
clear and relevant to patient care.  
5 Some of the functionality of this system may be difficult for 
patients to understand or use.  
6 I believe that patients will be able to learn to use this system 
easily.  
7 I have felt comfortable using this system for patient 
care.  
8 I have needed additional time to learn how to use this 
system correctly.  
 
VR headset rating - Quest 2  
Strongly  
disagree  
little  
disagree 
Neutral  
little  
agree 
I quite 
agree 
1 I think the weight and design of the glasses couldbe 
uncomfortable for patients. 
 
 
 
 
 
2 I think that the use of glasses and controls could be 
complicated for some patients. 
 
 
 
 
 
3 I think patients would be able to wear these glasses for 
an extended period of time without discomfort. 
 
 
 
 
 
 
 
COMMENTS:  
Protocol PI-23-195 Version: 2.0 - Date: 23/09/2023 Page 35 of 35