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NCT Number: NCT06579378

Feasibility Study of Virtual Sail 3D in Cognitive Functions

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Cagliari

Cagliari, CA, 09124, Italy

Location status: Recruiting

Location contact

Federica Sancassiani, Prof

CONTACT

[email protected]

00393493119215

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

VSail 3D

Device

The "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

The 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).

Primary outcomes

  1. Dropout rates; 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)

    Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.

  2. Simulator Sickness Questionnaire (SSQ)

    Time frame: 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.

  3. Self-report satisfaction questionnaire

    Time frame: 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 outcomes

  1. Trail Making Test

    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)

    Preliminary measure of effectiveness on executive functions

  2. Digit Span

    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)

    Preliminary measure of effectiveness on memory

  3. Stroop Test

    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)

    Preliminary measure of effectiveness on executive functions

  4. Rey Figure Test

    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)

    Preliminary measure of effectiveness on visual spatial function

  5. Frontal Assessment Battery (FAB)

    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)

    Preliminary measure of effectiveness on executive functions

  6. Matrix test

    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)

    Preliminary measure of effectiveness on selective attention

  7. Rey's Word Test

    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)

    Preliminary measure of effectiveness on memory

  8. Addenbrooke's Cognitive Examination (ACE-R)

    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)

    Preliminary measure of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.

Other outcomes

  1. Short Form Health Survey, 12 items (SF-12)

    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)

    Preliminary measure of effectiveness on quality of life, 12 item. The score range il 12-47, with higher scores indicating better quality of life.

  2. Patient Health Questionnaire (PHQ-9)

    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)

    Preliminary measure of effectiveness on depressive symptoms, 9 Item. The score range is 0-27, with higher scores indicating worse depressive symptoms.

  3. Generalized Anxiety Disorder-7 item (GAD-7)

    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)

    Preliminary measure of effectiveness on anxiety, 7 item. The score range is 0-21, with higher scores indicating worse anxious symptoms.

  4. Brief Social Rhythms Scale (BSRS)

    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)

    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.

  5. Physical Body Experiences Questionnaire Simplified for Active Aging (PBE-QAG)

    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)

    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.

  6. International Physical Activity Questionnaire (IPAQ)

    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)

    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.

  7. Sway area in the presence and absence of visual input

    Time frame: T0 (0 weeks); T1 (6 weeks)

    95% confidence ellipse calculated based on the center of pressure time-series acquired using a pressure baropodometric platform.

  8. Gait speed

    Time frame: T0 (0 weeks); T1 (6 weeks)

    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).

  9. Timed up and go time

    Time frame: T0 (0 weeks); T1 (6 weeks)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Sancassiani, Prof

CONTACT

[email protected]

00393493119215

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • Fondazione di Sardegna

Registry information

Official study title

Virtual Sail 3D - A Feasibility Study for Enhancing Cognitive Functions in Elderly People

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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