Trial0

Clinical trial · NCT06579378 · RECRUITING · NA

Feasibility Study of Virtual Sail 3D in Cognitive Functions

Sponsor: University of Cagliari

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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.

Interventions

  • 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).

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

  • University Hospital of Cagliari, Cagliari, CA, Italy · RECRUITING

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2024-08-30.