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用于轻度认知障碍个体的虚拟现实认知康复工具:一项可行性随机临床试验的研究方案

Virtual reality cognitive remediation tool for individuals with mild cognitive impairment: study protocol for a feasibility randomized clinical trial.

作者信息

Perra Alessandra, Primavera Diego, Leonetti Valerio, Montisci Roberta, Carta Daniele, Lorrai Giulia, Locci Aurora, Chessa Luchino, Scuteri Angelo, Cossu Giulia, Nardi Antonio Egidio, Valmaggia Lucia, Galetti Alessia, De Lorenzo Valerio, Sancassiani Federica, Carta Mauro Giovanni

机构信息

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Strategic Steering Commitee, Centro Studi SAPIS Foundation, Italian National Federation of Orders of Radiographers and Technical, Rehabilitation, and Prevention Health Professions Research Centre, Rome, Italy.

出版信息

Front Public Health. 2024 Nov 22;12:1477279. doi: 10.3389/fpubh.2024.1477279. eCollection 2024.

Abstract

INTRODUCTION

With the growing older adult population, the European Union emphasizes the need to promote research in healthy aging trough multidisciplinary and innovative approaches, including the integration of advanced technologies like virtual reality (VR) in cognitive rehabilitation. This reflects the increasing awareness of the importance of addressing challenges related to neurodegenerative diseases in the older adult population. Our study aims to present a protocol that will assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive CR technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI).

METHODS

A feasibility randomized controlled clinical study will involve 30 individuals who are over 65 years old, both sex, who meet the diagnostic criteria for MCI from the University Hospital of Cagliari, randomly assigned to either the experimental condition or control group. Both groups will continue to receive standard pharmacological therapy. The experimental group will undergo a 3-months cognitive remediation program using fully immersive VR with two sessions per week. Each session will last a maximum of 60 min and will be supervised by expert health professionals. In contrast, the control group will continue with standard care. The intervention program will be carried out by s psychiatric rehabilitation technicians and speech therapists, emphasizing a comprehensive framework aligned with healthcare needs. Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible and on side effects and level of satisfaction. The preliminary measures of effectiveness will be evaluated on quality of life, cognitive functions, biological and social rhythms, depressive symptoms and anxiety.

RESULTS

The trial findings will be submitted for publication in international peer-reviewed journals and shared at international meetings and conferences.

DISCUSSION

This study aiming to assess the feasibility and preliminary effectiveness of a fully immersive VR/CR program for MCI in order to give data for a subsequent confirmatory trial. The results of the pilot RCT are expected to significantly contribute to research on the prevention of neurocognitive degeneration, with a specific emphasis on enhancing the application of technologies. The strengths of this work are the high technological innovation program for mental health treatments for and multidisciplinary approach emphasizing a holistic framework aligned with health needs.

摘要

引言

随着老年人口的不断增加,欧盟强调需要通过多学科和创新方法来促进健康老龄化研究,包括将虚拟现实(VR)等先进技术整合到认知康复中。这反映出人们越来越意识到应对老年人群中与神经退行性疾病相关挑战的重要性。我们的研究旨在提出一项方案,该方案将评估使用沉浸式CR技术对轻度认知障碍(MCI)个体进行认知修复(CR)干预的可行性,并提供有效性的初步衡量指标。

方法

一项可行性随机对照临床研究将纳入30名65岁以上的个体,不限性别,他们符合卡利亚里大学医院MCI的诊断标准,随机分配到实验组或对照组。两组将继续接受标准药物治疗。实验组将使用完全沉浸式VR进行为期3个月的认知修复计划,每周两次。每次课程最长持续60分钟,并由专业健康专家监督。相比之下,对照组将继续接受标准护理。干预计划将由精神康复技术人员和言语治疗师实施,强调与医疗需求相一致的综合框架。可行性将基于耐受性进行评估,包括脱落率和可接受性,可接受性考虑在符合条件的招募参与者中的比例以及副作用和满意度水平。有效性的初步衡量指标将根据生活质量、认知功能、生物和社会节律、抑郁症状和焦虑进行评估。

结果

试验结果将提交至国际同行评审期刊发表,并在国际会议上分享。

讨论

本研究旨在评估针对MCI的完全沉浸式VR/CR计划的可行性和初步有效性,以便为后续的验证性试验提供数据。预计该初步随机对照试验的结果将对神经认知退化预防研究做出重大贡献,特别强调加强技术应用。这项工作的优势在于针对心理健康治疗的高科技创新计划以及强调与健康需求相一致的整体框架的多学科方法。

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