Feasibility Study of Virtual Sail 3D in Cognitive Functions
ConditionMild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Cagliari
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,"
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
VSail 3D
DeviceThe "CEREBRUM" software with virtual sailing scenarios is made up of exercises of variable difficulty, designed to train different cognitive functions, in particular attention, memory, learning, cognitive estimates, working memory, executive functions, motor abilities and language. The different degrees of difficulty are designed to adapt to the user's functional diagnosis. The operator who conducts the intervention must adapt the difficulty level to the user's residual abilities, so that the exercises are neither too easy nor too complex. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback, and suggestions of practical homework related to the cognitive function trained during the session that the individual should try during daily life.
WEB-Health
Other interventionThe intervention includes a series of 3 webinars focused on active ageing promotion. In particular, each webinar will regard topics related to healthy lifestyle, such as physical activity in old age, effective communication, stress management, technologies and health. Each webinar will be conducted by a mental health professional, and it will be delivered in real-time in a group (plenary).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VSail 3DExperimental treatment 1 intervention
Group B: WEB-HealthActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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)2
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.
Time frame
T0 (0 weeks) - T1 (6 weeks)3
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.
Time frame
T1 (6 weeks)Secondary outcomes
1
Trail Making Test
Preliminary measure of effectiveness on executive functions
Time frame
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)2
Digit Span
Preliminary measure of effectiveness on memory
Time frame
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)3
Stroop Test
Preliminary measure of effectiveness on executive functions
Time frame
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)4
Rey Figure Test
Preliminary measure of effectiveness on visual spatial function
Time frame
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 outcomes
1
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.
Time frame
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)2
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.
Time frame
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)3
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.
Time frame
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)4
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.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cagliari
Lead sponsor
Fondazione di Sardegna
Collaborator
Source ClinicalTrials.gov