Feasibility Study of Virtual Sail 3D in Cognitive Functions
NCT ID: NCT06579378
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-05-01
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
VSail 3D
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
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.
WEB-Health
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).
Interventions
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VSail 3D
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
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).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
65 Years
ALL
No
Sponsors
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Fondazione di Sardegna
UNKNOWN
University of Cagliari
OTHER
Responsible Party
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Federica Sancassiani
Principal Investigator
Locations
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University Hospital of Cagliari
Cagliari, CA, Italy
Countries
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Central Contacts
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Facility Contacts
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Federica Sancassiani, Prof
Role: primary
Other Identifiers
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NP/2023/2557
Identifier Type: -
Identifier Source: org_study_id