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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
A program consisting of 45-minute computer-based cognitive rehabilitation exercises, enhanced with 15-20 minutes of immersive virtual reality (VR) content per session. The VR component targets memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks.
A program consisting of 45-minute computer-based cognitive rehabilitation exercises targeting memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks. No VR content is included.
Centro Socio Sanitario El Carmen
Badalona, Barcelona, Spain
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
MoCA is a 30-point screening tool for global cognitive function, assessing memory, attention, language, visuospatial skills, and executive function. Score Range: 0 to 30 points \- Higher scores means better global cognition function
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
MMSE is a 30-point questionnaire evaluating orientation, attention, recall, language, and visual construction Score Range: 0 to 30 points. Higher scores means better global cognition function
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Short-Term Memory as Measured by the Digit Span Test (Forward Span)
Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points Higher scores reflect better performance.
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Working Memory as Measured by the Digit Span Test (Backward Span)
Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
TMT-A measures visual attention and processing speed. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better visuospatial attention.
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
TMT-B assesses alternating attention and executive control. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention.
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
SDMT: Symbol Digit Modalities Test. The Symbol Digit Modalities Test (SDMT) measures processing speed, attention, and visual-motor coordination. During the test, participants are required to match abstract symbols with corresponding numbers using a key. The total raw score is calculated as the number of correct symbol-digit pairs completed within a 90-second interval. There is no fixed maximum score, as it varies based on individual performance. Higher scores indicate better processing speed and cognitive performance.
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale
The Lawton-Brody Instrumental Activities of Daily Living Scale evaluates functional independence in activities such as telephone use, shopping, cooking, and managing finances. Scores range from 0 to 8, with higher scores indicating greater independence. Each task is scored as independent (1) or dependent (0).
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache). Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.
Time frame: Post-intervention (Week 12, within 1 week after last session)
Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale
Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache). Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.
Time frame: Post-intervention (Week 12, within 1 week after last session)
Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
An adapted SUS completed by professionals delivering the intervention. The 8 items assess perceived usability, integration into clinical workflow, and ease of use for patients. Score Range: 0 to 100 Interpretation: Higher scores indicate better usability.
Time frame: Post-intervention (Week 12, within 1 week after last session)
Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire
Professionals rate their perception of how comfortable and manageable the VR headset is for patients. The 3 items assess concerns such as weight, usability of controls, and prolonged wear tolerance. Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate better perceived comfort and usability for patients.
Time frame: Post-intervention (Week 12, within 1 week after last session)
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