Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Socios… (NCT06155721) | Clinical Trial Compass
CompletedNot Applicable
Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme
Spain45 participantsStarted 2023-10-30
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
Timeframe: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
2
Comfort of VR Headset as Measured by an 8-Item SUS:
Timeframe: immediately post-intervention, within 30 minutes after the 8th session (day 8)