Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.
This clinical trial evaluates a cognitive rehabilitation program enhanced with virtual reality (VR) for older adults with mild cognitive impairment (MCI). The study investigates whether adding immersive VR exercises to a conventional program improves cognitive performance compared to standard cognitive rehabilitation alone.
All participants take part in a structured, computer-based cognitive training program delivered over 12 weeks. Sessions occur twice per week, with participants completing at least 20 and up to 22 sessions depending on clinic scheduling. The intervention group receives an additional 15-20 minutes of immersive VR content at the end of each session. VR exercises target attention, memory, and executive functioning, aiming to increase engagement and therapeutic value.
This trial complements a previously registered pilot study (ClinicalTrials.gov Identifier: NCT06155721) and builds on its published results.
Cognitive performance will be assessed using standardized neuropsychological tests including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Digit Span, Trail Making Test (TMT), and Symbol Digit Modalities Test (SDMT). Functional capacity will be evaluated using the Lawton-Brody scale. Usability and satisfaction with the VR system will be measured in the intervention group using the System Usability Scale (SUS) and a custom satisfaction questionnaire.
The study was implemented pragmatically within routine clinical care. Allocation followed the pre-existing attendance schedule of the psychogeriatric day hospital. For logistical and ethical reasons related to service implementation, one comparator group was later offered the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. Analyses will distinguish unique participants from rehabilitation episodes to account for this sequential access.
The study has been approved by the Germans Trias i Pujol University Hospital Research Ethics Committee (PI-24-210) and complies with the Declaration of Helsinki and the European General Data Protection Regulation (GDPR).
Inclusion Criteria:
Adults aged ≥60 years, classified as having mild cognitive impairment or early cognitive impairment, with MMSE >20, regularly attending cognitive stimulation sessions at the CSSC day hospital and able to provide informed consent or consent through a legal representative.
Exclusion Criteria:
Severe or unstable illness interfering with participation, severe psychiatric symptoms that could be exacerbated by VR, severe visual or hearing impairment preventing participation, high sensitivity to motion sickness, epilepsy, or inability or unwillingness to provide informed consent.