跳至主要内容
临床试验/NCT05309005
NCT05309005招募中不适用

Virtual Reality and Social Cognition After Acquired Brain Injury

Sunnaas Rehabilitation Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Known Groups Validity of VR TASIT assessed with Mann Whitney U test

研究概览

简要总结

The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.

详细描述

The study's main aim is to validate a Norwegian virtual reality (VR) adaptation of The Awareness of Social Inference Test (TASIT) in an acquired brain injury population (ABI). The secondary aim is to increase our understanding of the interplay between social cognition and general cognition in a realistic social setting, i.e. an immersive virtual environment.

TASIT is one of the few available standardized tests of social cognition with good and documented norms and psychometric properties. The original TASIT consists of three subtests, one subtest measuring emotion recognition and two subtests measuring Theory of Mind. It has an A and a B form for retest purposes. Each subtest consists of short videos depicting various social scenes. The participant's task is to identify a character's emotions, beliefs or intentions, depending on the subtest. TASIT predicts social cognitive impairments in several patient groups, including ABI.

VR is an immersive, computer-generated three-dimensional environment. Computer- and behavioral interfaces are used to simulate the behavior of 3D entities that interact in real time with a user who is immersed in the virtual environment. VR facilitates a sense of social presence, i.e. a feeling of being part of social situations, not attainable in a two-dimensional medium. Assessing social cognition in a virtual environment with higher social presence could increase the test's ecological validity.

For the Norwegian version of TASIT the manuscripts from all videos from the A form were translated into Norwegian. The original dialogues and plot lines from the original test were retained, except minor adaptations for modernization purposes and to exploit the potential for social presence in VR. The scenes were filmed with a 360-degree camera, allowing production of one immersive three-dimensional VR version (VR TASIT) and a standard, two-dimensional desktop version (DT TASIT). The versions are otherwise identical.

Research Questions: The overall aim is to improve assessment and understanding of social cognitive impairment in patients with ABI. This will be done by investigating the psychometric properties and validity of a VR version of TASIT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in stable phase after acquired brain injury, minimum one year after injury
  • Physically able to operate VR technology
  • Norwegian skills adequate to understand instructions and dialogues in TASIT videos.

排除标准

  • Severe aphasia affecting their understanding of instructions
  • Apraxia affecting their ability to use VR-equipment
  • Visual neglect
  • Severe mental illness or co-existing neurological disorders

结局指标

主要结局

Known Groups Validity of VR TASIT assessed with Mann Whitney U test

时间窗: 60 minutes

It is expected that the patient group performs poorer than the control group on the VR TASIT, both total score and scores on each of the three subtests.

Reliability of VR TASIT in the patient group assessed with paired sample t-tests

时间窗: 60 minutes

The test-retest reliability of VR TASIT in the patient group is determined by re-administering the test 16 weeks after the first administration and calculating the correlation. Analysis of both total score and subscores will be conducted.

次要结局

  • Convergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.(60 minutes)
  • Ecological Validity of VR TASIT assessed with paired sample t-tests.(60 minutes)
  • Divergent Validity of VR TASIT in the patient group assessed with paired sample t-tests.(60 minutes)

研究者

发起方
Sunnaas Rehabilitation Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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