Feasibility Study of Virtual Sail 3D in Cognitive Functions
NCT Number: NCT06579378
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mild Cognitive Impairment
Interventions: DEVICE: VSail 3D|OTHER: WEB-Health
Sponsor: University of Cagliari
Collaborators: Fondazione di Sardegna
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2025-12-01
Locations: University Hospital of Cagliari, Cagliari, CA, 09124, Italy

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.

Primary Outcome Measures: Dropout rates; Proportion of recruited participants among those considered eligible;, Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the 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)|Simulator Sickness Questionnaire (SSQ), 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., T0 (0 weeks) - T1 (6 weeks)|Self-report satisfaction questionnaire, 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., T1 (6 weeks)
Secondary Outcome Measures: Trail Making Test, Preliminary measure of effectiveness on executive functions, 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)|Digit Span, Preliminary measure of effectiveness on memory, 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)|Stroop Test, Preliminary measure of effectiveness on executive functions, 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)|Rey Figure Test, Preliminary measure of effectiveness on visual spatial function, 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)|Frontal Assessment Battery (FAB), Preliminary measure of effectiveness on executive functions, 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)|Matrix test, Preliminary measure of effectiveness on selective attention, 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)|Rey's Word Test, Preliminary measure of effectiveness on memory, 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)|Addenbrooke's Cognitive Examination (ACE-R), Preliminary measure of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia., 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)
Other Outcome Measures: Short Form Health Survey, 12 items (SF-12), Preliminary measure of effectiveness on quality of life, 12 item. The score range il 12-47, with higher scores indicating better quality of life., 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)|Patient Health Questionnaire (PHQ-9), Preliminary measure of effectiveness on depressive symptoms, 9 Item. The score range is 0-27, with higher scores indicating worse depressive symptoms., 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)|Generalized Anxiety Disorder-7 item (GAD-7), Preliminary measure of effectiveness on anxiety, 7 item. The score range is 0-21, with higher scores indicating worse anxious symptoms., 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)|Brief Social Rhythms Scale (BSRS), Preliminary measure of effectiveness on dysregulation of biological and social rhythms, 10 item.

The score range is 10-60, with higher scores indicating worse dysregulation of rhythms., 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)|Physical Body Experiences Questionnaire Simplified for Active Aging (PBE-QAG), Preliminary measure of effectiveness on body awareness in people over 65 years old, 12 item.

The score range is 12-60, with higher scores indicating worse body awareness., 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)|International Physical Activity Questionnaire (IPAQ), Preliminary measure of effectiveness on level of physical activity carried out in the last 7 days, 9 item.

The total score is based on the conventional unit of measure "MET," where higher MET correspond to higher levels of physical activity. Typically, a score of less than 700 MET indicates a low level of physical activity, a score between 700 and 2519 MET indicates a moderate level of physical activity, and a score greater than or equal to 2520 MET indicates an intense level of physical activity., 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)|Sway area in the presence and absence of visual input, 95% confidence ellipse calculated based on the center of pressure time-series acquired using a pressure baropodometric platform., T0 (0 weeks); T1 (6 weeks)|Gait speed, Speed calculated on a 20 m straight trajectory. This is obtained by processing the trunk accelerations recorded by a single wearable inertial sensor (BTS-G-Sensor2) located in the low back (L5-S1 vertebrae)., T0 (0 weeks); T1 (6 weeks)|Timed up and go time, time needed to complete a 3m Timed-up-and-go (TUG) test. This will be carried out using a single wearable inertial sensor located in the low back (L2 vertebrae)., T0 (0 weeks); T1 (6 weeks)