Feasibility Study of Virtual Sail 3D in Cognitive Functions
- Conditions
- Mild Cognitive Impairment
- Interventions
- Device: VSail 3DOther: WEB-Health
- Registration Number
- NCT06579378
- Lead Sponsor
- University of Cagliari
- Brief Summary
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.
- Detailed Description
Research on active aging has been identified as a priority, particularly concerning the feasibility and effectiveness of non-pharmacological interventions aimed at preventing and/or delaying cognitive decline. Risk factors such as physical, cognitive, and social inactivity are estimated to account for about 40% of the risk of developing dementia in the lifetime. Recent reviews have shown that cognitive remediation interventions are effective in improving cognitive performance in older adults with and without cognitive decline.
Cognitive remediation is a behavior-based training intervention aimed at improving cognitive functions (memory, attention, executive functions, social cognition, and metacognition) to achieve lasting results and their generalization. There is substantial evidence supporting the effectiveness of such interventions in neuropsychological disorders such as dementia, mild cognitive impairment, and behavioral disorders.
In recent years, there has been an increase in the use of immersive 3D virtual reality software in clinical and rehabilitative settings as tools for rehabilitation and the improvement of various skills. To date, there are few studies where immersive 3D virtual reality is used to enhance cognitive functions related to personal and social functioning, especially to prevent cognitive decline in older adults (aged 65 and over).
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with sailing scenarious among elderly with mild cognitive impairment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age: 65 years or older
- Sex: all
- Living independently,
- Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D,"
- Without severe issues with autonomous mobility
- With Mild Cognitive Impairment (MCI) according to Addenbrooke's Cognitive Examination for cognitive functions (ACE-R), which also includes the Mini-Mental State Examination (MMSE), with the following ranges: ACE = 66.93-79.86 and/or MMSE = 21-25.
- Signing the informed consent
- severe cardiovascular conditions
- severe issues with autonomous mobility
- severe metabolic disorders not pharmacologically compensated
- severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.)
- severe ongoing bronchopulmonary disorders
- severe ongoing renal disorders
- glaucoma, retinal detachment, or other serious vision conditions that do not allow the safe use of 3D virtual reality technology
- active malignant neoplasm that do not allow the hinders participation in the intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VSail 3D VSail 3D The "VSail 3D" experimental protocol includes 12 sessions (2 times a week, for 6 consecutive weeks) with scenarios (virtual environments) dedicated to the sport of sailing. The duration of each session is 50-60 minutes. WEB-Health WEB-Health The intervention regards education on healthy lifestyles to promote active ageing (topics: physical activity in old age; effective communication, stress management, technologies and health). It will consist of 3 seminars, delivered in the form of webinars, on a bi-weekly basis over 6 consecutive weeks, lasting 50-60 minutes each.
- Primary Outcome Measures
Name Time Method Dropout rates; Proportion of recruited participants among those considered eligible; T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.
Simulator Sickness Questionnaire (SSQ) T0 (0 weeks) - T1 (6 weeks) Feasibility will be assessed based on side effects through the Simulator Sickness Questionnaire (SSQ), a self-report questionnaire that evaluates the frequency of unwanted effects that may occur due to the use of virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items.
The score range is 0-48, with higher scores indicating worse side effects.Self-report satisfaction questionnaire T1 (6 weeks) Feasibility will be assessed based on a Self-report satisfaction questionnaire, constructed ad hoc to evaluate the level of satisfaction with the program as a whole, the effect on psychophysical health, helping and listening abilities demonstrated by the operators, organizational support for activities, satisfaction with initial expectations.
The score range is 6-30, with higher scores indicating higher satisfaction.
- Secondary Outcome Measures
Name Time Method Trail Making Test T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on executive functions
Digit Span T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on memory
Stroop Test T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on executive functions
Rey Figure Test T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on visual spatial function
Frontal Assessment Battery (FAB) T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on executive functions
Matrix test T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on selective attention
Rey's Word Test T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on memory
Addenbrooke's Cognitive Examination (ACE-R) T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1) Preliminary measure of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.
Trial Locations
- Locations (1)
University Hospital of Cagliari
🇮🇹Cagliari, CA, Italy