N/A
Completed N=25
Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme
Source: ClinicalTrials.gov NCT06155721 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) — 81.9 score on a scale from 0-100
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) |
81.9 | — |
| PRIMARY Comfort of VR Headset as Measured by an 8-Item SUS: |
86.5 | — |
| SECONDARY Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: |
85.2 | — |
| SECONDARY VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: |
60.4 | — |
| SECONDARY Global Cognition as Measured by the Mini-Mental State Examination (MMSE) |
26; 26.5 | — |
| SECONDARY Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) |
19; 20 | — |
| SECONDARY Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) |
4.5; 4.5 | — |
| SECONDARY Working Memory as Measured by the Digit Span Test (DST Backward Span) |
3; 3 | — |
| SECONDARY Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A) |
70.5; 65.5 | — |
| SECONDARY Executive Function as Measured by the Trail Making Test Part B (TMT-B) |
195.5; 205 | — |
| SECONDARY Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT) |
17; 18.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06155721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.