Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli. The main questions it aims to answer are: Will patients with mild cognitive impairment find the VR program enjoyable and easy to use? Can VR interventions help improve patients' cognitive functions, specifically attention and memory? Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice? Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will: Engage with a VR-based cognitive stimulation program. Undergo assessments of the participants´ cognitive functions before and after the intervention. Provide feedback on the participants´ experience with the VR program. Researchers will analyze the data to see if: The VR program leads to noticeable improvements in the cognitive abilities of participants. The program is well-received and deemed beneficial by both patients and healthcare professionals.

Detailed Description
-----------------
Background: Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes. Study Design: This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience. Objectives: Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment. Secondary Objectives: To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program. To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program. To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation. To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback. To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments. Methodology: Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales. Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices. Expected Outcomes: It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications. Relevance: The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice. Conclusion: By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.

Official Title
-----------------
Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)

Conditions
-----------------
Cognitive Dysfunction, Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Device: Virtual Reality Cognitive Stimulation Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23. Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC). Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative. Exclusion Criteria: Patients with a severe or unstable illness that could interfere with participation in the study. Patients with serious 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. Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses. Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids. High sensitivity to motion sickness. Subjects with epilepsy. Patients who are unable or unwilling to give informed consent. Withdrawal Criteria The emergence of health problems that could interfere with the continuity of participation in the study, or the withdrawal of consent by the participant.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm interventional study where all participants receive the same intervention- a cognitive stimulation program administered through virtual reality (VR). Participants with mild to moderate cognitive impairment will engage in structured VR sessions aimed at stimulating cognitive functions, particularly attention and memory. The study will monitor participants' cognitive performance through standardized cognitive scales pre- and post-intervention, as well as gather subjective feedback on their experience to evaluate acceptability and motivation. Additionally, healthcare professionals' perceptions of the VR intervention's applicability to clinical practice will be assessed through structured interviews or questionnaires.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Cognitive Stimulation Program<br>Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). | Device: Virtual Reality Cognitive Stimulation Program<br>* Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of VR Exercises as Measured by an Adapted 8-Item SUS: | Adapted 8-Item System Usability Scale (SUS): Score Range: 8 to 40 points Interpretation: Higher scores indicate better usability. | immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8) | 
| Comfort of VR Headset as Measured by an 8-Item SUS: | Adapted 8-Item VR Headset Comfort Rating: Score Range: 8 to 40 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort). | immediately post-intervention, within 30 minutes after the 8th session (day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 8 to 40 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 3 to 15 points Interpretation: Lower scores indicate better comfort and ease of use for the VR headset; higher scores indicate greater discomfort and difficulty with use. This rating is based on a professional assessment of the VR headset's weight, design, and control scheme's impact on patient comfort during use. | immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Global cognition state as measured by the MMSE | MMSE: Mini mental State Examination. Score Range: 0 to 30 points. Higher scores means better global cognition function | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Global cognition state as measured by the MoCA | MoCA: Montreal Cognitive Assessment. Score Range: 0 to 30 points - Higher scores means better global cognition function | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Short Term Verbal Memory as measured by DST (forward span) | DST (forward span): Digit Span Test (forward span). Score Range: 0 to 9 points - Higher scores indicate better short-term verbal memory. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Working Memory as measure by the DST (backward span) | DST (backward span): Digit Span Test (backward span). Score Range: 0 to 9 points. Higher scores indicate better working memory. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Visuospatial Attention as measured by the TMTA | TMTA: Trial Making Test A. Score Range: Time to complete the test, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better visuospatial attention. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Alternating Attention as measured by the TMTB | TMTB: Trial Making Test B. Score Range: Time to complete the test, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 
| Processing Speed as measured by the SDMT | SDMT: Symbol Digit Modalities Test. Score Range: Number of correct substitutions within a set time limit (90 seconds), ranging from 0 to a maximum that can vary based on the individual's speed. Higher scores means better Processing Speed | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Stimulation, Virtual Reality, Mild Cognitive Impairment, Cognitive Rehabilitation