Feasibility Study of Virtual Sail 3D in Cognitive Functions

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 ex
• Другое 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).

Первичные конечные точки

• Dropout rates; Proportion of recruited participants among those considered eligible; [Срок оценки: 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) [Срок оценки: T0 (0 weeks) - T1 (6 weeks)]
• Self-report satisfaction questionnaire [Срок оценки: T1 (6 weeks)]

Вторичные конечные точки (8)

• Trail Making Test [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• University Hospital of Cagliari — Cagliari

Публикации

• Sancassiani F, Perra A, Vacca V, Montisci R, Monni M, Lorrai S, Cossu G, Petretto DR, di Natale L, Primavera D, Redolfi S, Scuteri A, Nardi AE, Kalcev G, Pau M, Carta MG. Enhancing Cognitive Functions in Older Adults With Mild Cognitive Impairment via Virtual Sail 3D: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 15;15:e85089. doi: 10.2196/85089. PMID 41538788

Идентификаторы

NCT: NCT06579378 · NP/2023/2557

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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