Cognitive Dysfunction, Mild Cognitive Impairment
Conditions
Keywords
Cognitive Stimulation, Virtual Reality, Mild Cognitive Impairment, Cognitive Rehabilitation
Brief summary
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: * Will patients with mild cognitive impairment find the VR program enjoyable and easy to use? * Can VR interventions help improve patients' cognitive functions, specifically attention and memory? * Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice? 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: * Engage with a VR-based cognitive stimulation program. * Undergo assessments of the participants´ cognitive functions before and after the intervention. * Provide feedback on the participants´ experience with the VR program. Researchers will analyze the data to see if: * The VR program leads to noticeable improvements in the cognitive abilities of participants. * The program is well-received and deemed beneficial by both patients and healthcare professionals.
Detailed description
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.
Interventions
DEVICEVirtual 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.
Sponsors
Badalona Serveis Assistencials
Public Health Agency of Barcelona
Reality Telling SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23. * Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC). * Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.
Exclusion criteria
* Patients with a severe or unstable illness that could interfere with participation in the study. * Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality. * Patients with severe visual limitations that would prevent the use of virtual reality. * Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses. * Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids. * High sensitivity to motion sickness. * Subjects with epilepsy. * Patients who are unable or unwilling to give informed consent. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) | 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. |
| Comfort of VR Headset as Measured by an 8-Item SUS: | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: | Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8) | 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. |
| VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: | immediately post-intervention, within 30 minutes after the 8th session (day 8) | 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. |
| Global Cognition as Measured by the Mini-Mental State Examination (MMSE) | 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 |
| Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) | 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 |
| Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) | 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. |
| Working Memory as Measured by the Digit Span Test (DST Backward Span) | 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. |
| Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A) | 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. |
| Executive Function as Measured by the Trail Making Test Part B (TMT-B) | 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. |
| Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT) | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJose Ferrer Costa, MD
Medical Researcher and Project Manager
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Virtual Reality Cognitive Stimulation Program |
|---|---|
| Age, Continuous | 75 years STANDARD_DEVIATION 5.9 |
| Alternating Attention as Measured by the TMTB | 202 seconds STANDARD_DEVIATION 425.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Global Cognition State as Measured by the MMSE | 25.98 units on a score 0-30 STANDARD_DEVIATION 2.02 |
| Global Cognition State as Measured by the MoCA | 17.98 units on a score 0-30 STANDARD_DEVIATION 4.35 |
| Processing Speed as Measured by the SDMT | 17 number of correct corresponding pairs STANDARD_DEVIATION 9.5 |
| Region of Enrollment Spain | 45 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 18 Participants |
| Short Term Verbal Memory as Measured by DST (Forward Span) | 4 units on a score 0-9 STANDARD_DEVIATION 1.07 |
| Visuospatial Attention as Measured by the TMTA | 66 seconds STANDARD_DEVIATION 49.42 |
| Working Memory as Measure by the DST (Backward Span) | 3 units on a score 0-9 STANDARD_DEVIATION 0.93 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 2 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
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).
Time frame: immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Comfort of VR Headset as Measured by an 8-Item SUS: | 86.5 score on a scale from 0-100 | Standard Deviation 13.3 |
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.
Time frame: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | 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 |
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.
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Executive Function as Measured by the Trail Making Test Part B (TMT-B) | 195.5 seconds | Standard Deviation 421 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Executive Function as Measured by the Trail Making Test Part B (TMT-B) | 205 seconds | Standard Deviation 426 |
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
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Global Cognition as Measured by the Mini-Mental State Examination (MMSE) | 26 score on a scale | Standard Deviation 2.12 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Global Cognition as Measured by the Mini-Mental State Examination (MMSE) | 26.5 score on a scale | Standard Deviation 2.3 |
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
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) | 19 score on a scale | Standard Deviation 4.19 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) | 20 score on a scale | Standard Deviation 4.4 |
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.
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT) | 17 Number of correct corresponding pairs | Standard Deviation 9.8 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT) | 18.5 Number of correct corresponding pairs | Standard Deviation 9.5 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | 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
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.
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) | 4.5 score on a scale | Standard Deviation 1.1 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) | 4.5 score on a scale | Standard Deviation 0.96 |
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.
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A) | 70.5 seconds | Standard Deviation 50.4 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A) | 65.5 seconds | Standard Deviation 38.3 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | 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
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.
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Working Memory as Measured by the Digit Span Test (DST Backward Span) | 3 score on a scale | Standard Deviation 0.97 |
| Post-Intervention - Virtual Reality Cognitive Stimulation Program | Working Memory as Measured by the Digit Span Test (DST Backward Span) | 3 score on a scale | Standard Deviation 0.77 |
Other Pre-specified
Demographics Variables
Age: numeric
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Demographics Variables | 75.5 years | Standard Deviation 6.19 |
Other Pre-specified
Demographics Variables
Gender: 0=female, 1=male, 3=others
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Demographics Variables | Male | 17 Participants |
| Virtual Reality Cognitive Stimulation Program | Demographics Variables | Female | 23 Participants |