Trial Outcomes & Findings for Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme (NCT NCT06155721)
NCT ID: NCT06155721
Last Updated: 2025-05-23
Results Overview
Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
Results posted on
2025-05-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Pilot Group 1
STARTED
|
25
|
|
Pilot Group 1
COMPLETED
|
23
|
|
Pilot Group 1
NOT COMPLETED
|
2
|
|
Pilot Group 2
STARTED
|
20
|
|
Pilot Group 2
COMPLETED
|
17
|
|
Pilot Group 2
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme
Baseline characteristics by cohort
| Measure |
Virtual Reality Cognitive Stimulation Program
n=45 Participants
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.
|
|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
45 participants
n=5 Participants
|
|
Global Cognition State as Measured by the MMSE
|
25.98 units on a score 0-30
STANDARD_DEVIATION 2.02 • n=5 Participants
|
|
Global Cognition State as Measured by the MoCA
|
17.98 units on a score 0-30
STANDARD_DEVIATION 4.35 • n=5 Participants
|
|
Short Term Verbal Memory as Measured by DST (Forward Span)
|
4 units on a score 0-9
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
Working Memory as Measure by the DST (Backward Span)
|
3 units on a score 0-9
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Visuospatial Attention as Measured by the TMTA
|
66 seconds
STANDARD_DEVIATION 49.42 • n=5 Participants
|
|
Alternating Attention as Measured by the TMTB
|
202 seconds
STANDARD_DEVIATION 425.04 • n=5 Participants
|
|
Processing Speed as Measured by the SDMT
|
17 number of correct corresponding pairs
STANDARD_DEVIATION 9.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=42 Participants
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.
|
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.
|
|---|---|---|
|
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
|
81.9 score on a scale from 0-100
Standard Deviation 14.9
|
—
|
PRIMARY outcome
Timeframe: immediately post-intervention, within 30 minutes after the 8th session (day 8)Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=42 Participants
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.
|
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.
|
|---|---|---|
|
Comfort of VR Headset as Measured by an 8-Item SUS:
|
86.5 score on a scale from 0-100
Standard Deviation 13.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)Population: 4 healthcare professionals that have used the VR headsets with patients
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.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=4 Participants
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.
|
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.
|
|---|---|---|
|
Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:
|
85.2 score on a scale from 0-100
Standard Deviation 10.9
|
—
|
SECONDARY outcome
Timeframe: immediately post-intervention, within 30 minutes after the 8th session (day 8)Population: 4 healthcare professionals that have used the VR headset with the patients
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.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=4 Participants
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.
|
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.
|
|---|---|---|
|
VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:
|
60.4 score on a scale from 0-100
Standard Deviation 22.9
|
—
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)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
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
|
26 score on a scale
Standard Deviation 2.12
|
26.5 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)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
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
|
19 score on a scale
Standard Deviation 4.19
|
20 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points \- Higher scores indicate better short-term verbal memory.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)
|
4.5 score on a scale
Standard Deviation 1.1
|
4.5 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Working Memory as Measured by the Digit Span Test (DST Backward Span)
|
3 score on a scale
Standard Deviation 0.97
|
3 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)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.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
|
70.5 seconds
Standard Deviation 50.4
|
65.5 seconds
Standard Deviation 38.3
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)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.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
|---|---|---|
|
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
|
195.5 seconds
Standard Deviation 421
|
205 seconds
Standard Deviation 426
|
SECONDARY outcome
Timeframe: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)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.
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
Post-Intervention - Virtual Reality Cognitive Stimulation Program
n=40 Participants
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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|---|---|---|
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Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
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17 Number of correct corresponding pairs
Standard Deviation 9.8
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18.5 Number of correct corresponding pairs
Standard Deviation 9.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAge: numeric
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
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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|---|---|---|
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Demographics Variables
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75.5 years
Standard Deviation 6.19
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineGender: 0=female, 1=male, 3=others
Outcome measures
| Measure |
Virtual Reality Cognitive Stimulation Program
n=40 Participants
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.
|
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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|---|---|---|
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Demographics Variables
Male
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17 Participants
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—
|
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Demographics Variables
Female
|
23 Participants
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—
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Adverse Events
Virtual Reality Cognitive Stimulation Program
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Virtual Reality Cognitive Stimulation Program
n=45 participants at risk
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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Ear and labyrinth disorders
Cybersickness
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4.4%
2/45 • Number of events 2 • Adverse event data were collected over a 3-month period during the pilot study.
0
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place