跳至主要内容
临床试验/CTRI/2025/04/085745
CTRI/2025/04/085745招募中不适用

Virtual Reality Games for Cognitive Assessment (VR-GCA) in MCI Subjects: A cross-sectional observational study.

EvoReality Pvt. Limited1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
1. ACE, Trail Making, DSST, Verbal Learning, Visuospatial, IADL-E, Lifestyle questionnaire, IQ CODE

研究概览

简要总结

Introduction

Proposed research aims to test novel tools of cognitive assessment based on Virtual Reality and Tablet/Laptop on people with mild cognitive impairment (MCI). Given the limitations of the traditional neuropsychological assessment tools in estimating the real-world abilities, and lack of power for capturing early-stage cognitive deterioration, novel tools based on VR/Tablet can provide deeper insights. Research on these tools is at a preliminary stage globally and no large-scale studies in India currently exist. Given the wide population of India and the lack of adequate neurologists, there is a need for technology-based tools for efficient decision making into the cognitive health of the people, especially elderly group.

Justification / need for the study

There are currently no large-scale studies in India on the clinical population (MCI) using VR games for cognitive assessment. The study provides an opportunity to experiment on novel and emerging tools like VR for cognitive assessment. Given the limitations of the traditional neuropsychological tests (Chaytor & Schmitter-Edgecombe, 2003; Sbordone & Long, 1996; Spooner & Pachana, 2006), VR based games for cognitive assessment provide greater opportunities to assess cognitive abilities in real-world type environments.

 Furthermore, due to the 3D immersive nature of the Virtual Reality (VR), the games can mimic the real-world cognitive load, thereby provide more realistic assessment of functional cognitive abilities of the participants. Potentially, this ability to provide ecologically valid assessment can lead to early detection of non-symptomatic cognitive decline.

Project Aim

The aim of this project is to pilot, and evaluate the Virtual Reality based goal-oriented games in the MCI people and to obtain feedback from the primary stakeholders in the clinical settings, such as caregivers, physicians, nurses, neurologist and allied specialists. Through the results of these, we also aim to arrive at a definitive understanding of the efficacy of the VR-based cognitive assessment and rehabilitation in the Indian scenario.

-       Objectives

1.     Pilot the 2 VR-based Games and 2 Tablet based games in MCI patients and compare their scores against the ACE-III and MoCA Scores of the patients.

2.     Based on the results of Objective (1) analyse the findings in context of simultaneous ACE-III administration among the MCI patients.

  1. Conduct qualitative interviews with the caregivers, medical personnel and patients about the use of VR games for cognitive assessment and document the feedback of each stakeholder in detail.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age 60 years and above.
  • Diagnosed with MCI.
  • Able to understand written and verbal English/Hindi/Kannada/Tamil.
  • Willing to complete the questionnaires that form the part of the study.

排除标准

  • Disability that hinders participation in the study.
  • Medically unstable
  • Motor or non-motor neurological deficits that hinder participation in the study.
  • Diagnosed with a contagious condition
  • History of epilepsy.
  • History of vertigo or diagnosed with vestibular disorders.
  • Prone to motion sickness.
  • Other severe psychiatric disturbances.

结局指标

主要结局

1. ACE, Trail Making, DSST, Verbal Learning, Visuospatial, IADL-E, Lifestyle questionnaire, IQ CODE

时间窗: All outcomes are measured at baseline.

2. VR Games scores

时间窗: All outcomes are measured at baseline.

3. Tablet game scores

时间窗: All outcomes are measured at baseline.

4. Game feedback

时间窗: All outcomes are measured at baseline.

次要结局

  • Perception & experience of MCI patients on game-based assessments.(Baseline)

研究者

发起方
EvoReality Pvt. Limited
申办方类型
Other [Private Company]
责任方
Principal Investigator
主要研究者

Veeky Baths

Cognitive Neuroscience Lab, Department of Biological Sciences

研究点 (1)

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