跳至主要内容
临床试验/NCT06597591
NCT06597591招募中不适用

Acceptability of a VR-based Training for Inhibitory Control in Subjects With Neurocognitive Disorders

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire

研究概览

简要总结

Executive function disorders, such as inhibitory control (IC) difficulties, are very common in older adults with neurocognitive disorders (NCD). Management of these disorders is possible using traditional tools and tools based on new technologies, such as serious games and virtual reality (VR). However, today, few immersive tools exist that are specifically focused on IC training. The present study aims to evaluate the acceptability of an immersive application focused on IC in 48 patients with neurocognitive disorders. Participants that will test either an immersive (VR-headset) or a non-immersive (tablet) version of the application for 4 weeks, twice a week, and fill-in acceptability related questionnaires before, during and after the end of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consulting the Nice hospital Memory Center
  • diagnosis of Mild Neurocognitve Disorder or slight major neurocognitive disorder (DSM V)
  • 60 years old or more
  • presence of deficits in inhibitory control as assessed by the Frontal Assessment Battery
  • fluent in French
  • able to understand the informed consent form and voluntarily consents to participate

排除标准

  • presence of significant vision or motor problems which would impact ability to perform the task
  • significant self-reported motion sickness
  • vulnerable persons as defined in articles L1121-5 to 8 of the French Public Health Code

研究组 & 干预措施

Serious game on tablet ( non Immersive VR)

Experimental

After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet.

干预措施: Tablet (Device)

Waiting Serious game on VR headset (Waiting immersive VR)

Experimental

2-month after enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.

干预措施: VR headset (Device)

Waiting Serious game on tablet ( Waiting non Immersive VR)

Experimental

2-month after enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.

干预措施: Tablet (Device)

Serious game on VR headset ( immersive VR)

Experimental

After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.

干预措施: VR headset (Device)

结局指标

主要结局

Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire

时间窗: at inclusion

Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions.. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.

UTAUT 2 Questionnaire

时间窗: at 24-week

Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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