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

NCT06155721 | Completed Results

• 1 other identifier: PI-23-195
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Mild Cognitive Impairment

Keywords

Cognitive Stimulation; Virtual Reality; Mild Cognitive Impairment; Cognitive Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)

  Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 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: 0 to 100 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 Outcomes (9)

• Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:

  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:

  immediately post-intervention, within 30 minutes after the 8th session (day 8)

• Global Cognition as Measured by the Mini-Mental State Examination (MMSE)

  Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

• Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)

  Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

• Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)

  Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

Other Outcomes (2)

• Demographics Variables

  Baseline

• Demographics Variables

  Baseline

Study Arms (1)

Virtual Reality Cognitive Stimulation Program

EXPERIMENTAL

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

Interventions

Virtual Reality Cognitive Stimulation Program DEVICE

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.

Virtual Reality Cognitive Stimulation Program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Badalona Serveis Assistencials: lead
• Public Health Agency of Barcelona: collaborator
• Reality Telling SL: collaborator

Study Sites (1)

Centro Socio Sanitario El Carmen

Badalona, Barcelona, 08917, Spain

Location

Related Publications (8)

• Bauer ACM, Andringa G. The Potential of Immersive Virtual Reality for Cognitive Training in Elderly. Gerontology. 2020;66(6):614-623. doi: 10.1159/000509830. Epub 2020 Sep 9.

  PMID: 32906122 BACKGROUND

• Liao YY, Chen IH, Lin YJ, Chen Y, Hsu WC. Effects of Virtual Reality-Based Physical and Cognitive Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild Cognitive Impairment: A Randomized Control Trial. Front Aging Neurosci. 2019 Jul 16;11:162. doi: 10.3389/fnagi.2019.00162. eCollection 2019.

  PMID: 31379553 BACKGROUND

• Gomez-Caceres B, Cano-Lopez I, Alino 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. 2023 Oct;37(7):1337-1370. doi: 10.1080/13854046.2022.2148283. Epub 2022 Nov 23.

  PMID: 36416175 BACKGROUND

• Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. 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. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987.

  PMID: 35044320 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Zuschnegg J, Schoberer D, Haussl A, Herzog SA, Russegger S, Ploder K, Fellner M, Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schussler 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 BACKGROUND

Related Links

• Organización de las Naciones Unidas. (2015). World population ageing. Department of Economic and Social Affairs, Population Division.
• Organización Mundial de la Salud. (2023). Demencia, 15 de marzo de 2023. Datos y cifras.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jose Ferrer Costa
• Organization: Badalona Serveis Assistencials

jfcosta@bsa.cat

+34 937407482

Study Officials

• Jose Ferrer Costa, MD

  Medical Researcher and Project Manager

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was involved in this study as all participants received the same intervention (the cognitive stimulation program using virtual reality created in collaboration with Reality Telling SL), and the open-label nature of the intervention made it impractical to blind participants or researchers to the treatment being provided.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: December 4, 2023
• Study Start: October 30, 2023
• Primary Completion: February 27, 2024
• Study Completion: March 27, 2024
• Last Updated: May 23, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)