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| Name | Class |
|---|---|
| Public Health Agency of Barcelona | OTHER |
| Reality Telling SL | UNKNOWN |
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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:
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:
Researchers will analyze the data to see if:
Background:
Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.
Study Design:
This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.
Objectives:
Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment.
Secondary Objectives:
To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program.
To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program.
To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation.
To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback.
To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments.
Methodology:
Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales.
Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices.
Expected Outcomes:
It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications.
Relevance:
The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice.
Conclusion:
By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Experimental | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Device | Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) | Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability. | immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8) |
| Comfort of VR Headset as Measured by an 8-Item SUS: | Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort). | immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics Variables | Age: numeric | Baseline |
| Demographics Variables | Gender: 0=female, 1=male, 3=others | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jose Ferrer Costa, MD | Medical Researcher and Project Manager | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Socio Sanitario El Carmen | Badalona | Barcelona | 08917 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Journal of Medical Extended RealityVol. 2, No. 1 Published Online: 21 March 2025 Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment Authors: Jose Ferrer Costa, Maria Jose Ciudad, Maribel González Abad, and José Luis Rodríguez García | ||
| 36674283 | Background | Perra A, Riccardo CL, De Lorenzo V, De Marco E, Di Natale L, Kurotschka PK, Preti A, Carta MG. Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies. Int J Environ Res Public Health. 2023 Jan 14;20(2):1527. doi: 10.3390/ijerph20021527. | |
| 37041494 |
| Label | URL |
|---|---|
| Organización Mundial de la Salud. (2023). Demencia, 15 de marzo de 2023. Datos y cifras. | View source |
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Not applicable; individual participant data will not be shared.
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The study included two separately recruited pilot groups of patients with mild cognitive impairment (MCI) participating in cognitive stimulation sessions at our outpatient unit. Group 1 (n = 25) was enrolled in Period 1 (Mondays and Wednesdays), and Group 2 (n = 20) in Period 2 (Tuesdays and Thursdays), each after applying inclusion criteria. Each group was independent, with no participant overlap. So the number of participants in Period 2 does not correspond to the number completing Period 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Cognitive Stimulation Program | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. Our pilot for memory stimulation initially targeted 20 participants. However, due to a high number of volunteers, we increased the sample size and organized it into two groups: one with 25 participants and the other with 20. This adjustment ensures robust data collection and analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pilot Group 1 |
|
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| 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 | Sep 23, 2023 |
Not provided
This is a single-arm interventional study where all participants receive the same intervention- a cognitive stimulation program administered through virtual reality (VR). Participants with mild to moderate cognitive impairment will engage in structured VR sessions aimed at stimulating cognitive functions, particularly attention and memory. The study will monitor participants' cognitive performance through standardized cognitive scales pre- and post-intervention, as well as gather subjective feedback on their experience to evaluate acceptability and motivation. Additionally, healthcare professionals' perceptions of the VR intervention's applicability to clinical practice will be assessed through structured interviews or questionnaires.
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No masking was involved in this study as all participants received the same intervention (the cognitive stimulation program using virtual reality created in collaboration with Reality Telling SL), and the open-label nature of the intervention made it impractical to blind participants or researchers to the treatment being provided.
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|
| VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate better comfort and ease of use for the VR headset; lower scores indicate greater discomfort and difficulty with use. This rating is based on a professional assessment of the VR headset's weight, design, and control scheme's impact on patient comfort during use. | immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| 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, within 30 minutes after the 8th session (day 8) |
| 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, within 30 minutes after the 8th session (day 8) |
| Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) | Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points - Higher scores indicate better short-term verbal memory. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| Working Memory as Measured by the Digit Span Test (DST 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, within 30 minutes after the 8th session (day 8) |
| 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, within 30 minutes after the 8th session (day 8) |
| Executive Function as Measured by the Trail Making Test Part B (TMT-B) | TMTB: Trial Making Test B. Score Range: Time to complete the test measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention. | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| 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, within 30 minutes after the 8th session (day 8) |
| Background |
| Zuschnegg J, Schoberer D, Haussl A, Herzog SA, Russegger S, Ploder K, Fellner M, Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schussler S. Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. BMC Geriatr. 2023 Apr 12;23(1):229. doi: 10.1186/s12877-023-03941-y. |
| 32906122 | Background | Bauer ACM, Andringa G. The Potential of Immersive Virtual Reality for Cognitive Training in Elderly. Gerontology. 2020;66(6):614-623. doi: 10.1159/000509830. Epub 2020 Sep 9. |
| 31379553 | Background | Liao YY, Chen IH, Lin YJ, Chen Y, Hsu WC. Effects of Virtual Reality-Based Physical and Cognitive Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild Cognitive Impairment: A Randomized Control Trial. Front Aging Neurosci. 2019 Jul 16;11:162. doi: 10.3389/fnagi.2019.00162. eCollection 2019. |
| 36416175 | Background | Gomez-Caceres B, Cano-Lopez I, Alino M, Puig-Perez S. Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. Clin Neuropsychol. 2023 Oct;37(7):1337-1370. doi: 10.1080/13854046.2022.2148283. Epub 2022 Nov 23. |
| 35044320 | Background | Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987. |
| 35811514 | Background | Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 10.3233/JAD-210672. |
| 35839753 | Background | Qiu R, Gu Y, Xie C, Wang Y, Sheng Y, Zhu J, Yue Y, Cao J. Virtual reality-based targeted cognitive training program for Chinese older adults: A feasibility study. Geriatr Nurs. 2022 Sep-Oct;47:35-41. doi: 10.1016/j.gerinurse.2022.06.007. Epub 2022 Jul 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Pilot Group 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Cognitive Stimulation Program | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Global Cognition State as Measured by the MMSE | MMSE: Mini mental State Examination. Score Range: 0 to 30 points. Higher scores means better global cognition function | Median | Standard Deviation | units on a score 0-30 |
| ||||||||||||||||
| Global Cognition State as Measured by the MoCA | MoCA: Montreal Cognitive Assessment. Score Range: 0 to 30 points- Higher scores means better global cognition function | Median | Standard Deviation | units on a score 0-30 |
| ||||||||||||||||
| Short Term Verbal Memory as Measured by DST (Forward Span) | DST (forward span): Digit Span Test (forward span). Score Range: 0 to 9points - Higher scores indicate better short-term verbal memory. If reporting a score on a scale, please include the unabbreviated scale t | Median | Standard Deviation | units on a score 0-9 |
| ||||||||||||||||
| Working Memory as Measure by the DST (Backward Span) | DST (backward span): Digit Span Test (backward span). Score Range: 0to 9 points. Higher scores indicate better working memory | Median | Standard Deviation | units on a score 0-9 |
| ||||||||||||||||
| Visuospatial Attention as Measured by the TMTA | TMTA: Trial Making Test A. Score Range: Time to complete the test measured in seconds,typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better visuospatial attention. | Median | Standard Deviation | seconds |
| ||||||||||||||||
| Alternating Attention as Measured by the TMTB | TMTB: Trial Making Test B. Score Range: Time to complete the test measured in seconds, typically ranging from several seconds to several minutes. | Median | Standard Deviation | seconds |
| ||||||||||||||||
| Processing Speed as Measured by the SDMT | 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. | Median | Standard Deviation | number of correct corresponding pairs |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) | Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability. | Posted | Mean | Standard Deviation | score on a scale from 0-100 | immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8) |
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| ||||||||||||||||||||||||||
| Primary | Comfort of VR Headset as Measured by an 8-Item SUS: | Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort). | Posted | Mean | Standard Deviation | score on a scale from 0-100 | immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care. | 4 healthcare professionals that have used the VR headsets with patients | Posted | Mean | Standard Deviation | score on a scale from 0-100 | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| |||||||||||||||||||||||||||
| Secondary | VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: | Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate better comfort and ease of use for the VR headset; lower scores indicate greater discomfort and difficulty with use. This rating is based on a professional assessment of the VR headset's weight, design, and control scheme's impact on patient comfort during use. | 4 healthcare professionals that have used the VR headset with the patients | Posted | Mean | Standard Deviation | score on a scale from 0-100 | immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | Standard Deviation | score on a scale | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Median | Standard Deviation | score on a scale | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) | Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points - Higher scores indicate better short-term verbal memory. | Posted | Median | Standard Deviation | score on a scale | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | Working Memory as Measured by the Digit Span Test (DST Backward Span) | Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory. | Posted | Median | Standard Deviation | score on a scale | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | Standard Deviation | seconds | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | Executive Function as Measured by the Trail Making Test Part B (TMT-B) | TMTB: Trial Making Test B. Score Range: Time to complete the test measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention. | Posted | Median | Standard Deviation | seconds | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | Standard Deviation | Number of correct corresponding pairs | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Demographics Variables | Age: numeric | Posted | Median | Standard Deviation | years | Baseline |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Demographics Variables | Gender: 0=female, 1=male, 3=others | Posted | Count of Participants | Participants | Baseline |
|
Adverse event data were collected over a 3-month period during the pilot study.
0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Cognitive Stimulation Program | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. | 0 | 45 | 0 | 45 | 2 | 45 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cybersickness | Ear and labyrinth disorders | Systematic Assessment | Two participants experienced cybersickness as dizziness. Symptoms resolved in less than 5 minutes after stopping VR. Both participants were willing to continue VR later. One had 3 sessions, and the other had 6 sessions |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Ferrer Costa | Badalona Serveis Assistencials | +34 937407482 | jfcosta@bsa.cat |
| Feb 24, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Unknown or Not Reported |
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| Post-Intervention - Virtual Reality Cognitive Stimulation Program |
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
|
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| OG001 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program |
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
|
|
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
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Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
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| OG001 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program |
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
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| Post-Intervention - Virtual Reality Cognitive Stimulation Program |
Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
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| OG001 | Post-Intervention - Virtual Reality Cognitive Stimulation Program | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Virtual Reality Cognitive Stimulation Program: Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. |
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