Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Enhanced Cognitive Rehabilitation | Experimental | Participants receive a computer-based cognitive rehabilitation program supplemented with immersive virtual reality exercises. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. |
|
| Standard Cognitive Rehabilitation | Active Comparator | Participants receive a standard computer-based cognitive rehabilitation program. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-Enhanced Cognitive Rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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. | 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. | Baseline and immediately post-intervention (Week 12, within 1 week after last session) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Age | Age in years, collected at baseline. Used to describe the study population and for subgroup analysis if needed. | Baseline |
| Participant Sex | Self-reported biological sex, categorized as: 0 = Female 1 = Male 3 = Other Collected at baseline to describe participant characteristics. |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Socio Sanitario El Carmen | Badalona | Barcelona | 08917 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment Jose Ferrer Costa, Maria Jose Ciudad, Maribel González Abad, and José Luis RodrÃguez GarcÃa Journal of Medical Extended Reality 2025 2:1, 30-42 |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 16, 2024 |
Not provided
Participants were allocated according to pre-existing attendance groups in the psychogeriatric day hospital. One group received standard cognitive rehabilitation supplemented with virtual reality (VR), while the comparator group received standard cognitive rehabilitation alone. For pragmatic service-implementation reasons, one comparator group was subsequently offered access to the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. This sequential access was based on clinical logistics and did not involve randomization or allocation concealment.
Not provided
Not provided
No masking; participants and facilitators are aware of group allocation due to the nature of the intervention.
Not provided
|
|
| Standard Cognitive Rehabilitation | Behavioral | 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. |
|
|
| 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. | 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. | 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). | Baseline and immediately post-intervention (Week 12, within 1 week after last session) |
| 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. | 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. | 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. | Post-intervention (Week 12, within 1 week after last session) |
| Baseline |
| Jul 6, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided