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Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

2017年5月6日 更新者:Alon Reshef、HaEmek Medical Center, Israel

Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

研究概览

详细说明

Background:

Schizophrenia often reflect by decrease in executive functions that may cause difficulty in Instrumental Activities of Daily Living (IADL). We've found it very difficult to simulate these functions with the existing tools in the clinic and to assess IADL accordingly.

The use of Virtual Reality (VR) became popular in the last decade to overcome these limitations in clinical practice and assessment of functioning in IADL. VR is a computer program that simulates a functional environment in which the subject impacts on events through various actions. Recent studies indicated that VR can be used to assess cognitive abilities and functioning of population with schizophrenia. As far as we know, no researches were performed using Virtual Interactive Shopping (VIS) in this population, nor did dynamic evaluation was used to identify potential learning abilities. The aim of this study is to examine the validity of the shopping task in the VIS, performed statically and dynamically, in order to assess executive function, and the ability to reflect cognitive, functional and participation ability among people that diagnosed with schizophrenia.

Method:

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

研究类型

介入性

注册 (预期的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment

Exclusion Criteria:

  • score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Hospitalization patients
patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress.

Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction

其他名称:
  • SeeMe
实验性的:Ambulatory patients
patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress.

Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction

其他名称:
  • SeeMe

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Modified 4 item test
大体时间:through study completion, an average of 1 year
"buy" 4 items with budget constraints, using the VIS
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Revised Observed Tasks of Daily Living (OTDL-R)
大体时间:through study completion, an average of 1 year
evaluation of IADL using various tasks include problem solving
through study completion, an average of 1 year
Executive Function Performance Test (EFPT)
大体时间:through study completion, an average of 1 year
executive function assessment using 5 different tasks
through study completion, an average of 1 year
Trail Making Test A & B (TMT)
大体时间:through study completion, an average of 1 year
The Trail Making Test is an accessible neuropsychological instrument that provides the examiner with information on a wide range of cognitive skills and can be completed in 5-10 min.
through study completion, an average of 1 year
The positive and negative syndrome scale (PANSS)
大体时间:through study completion, an average of 1 year
The Positive and Negative Syndrome Scale (PANSS) was developed out of the need for a well-operationalized method of assessing these syndromes in schizophrenia, including their relationship to one another and to global psychopathology
through study completion, an average of 1 year
Adults Subjective Assessment of Participation
大体时间:through study completion, an average of 1 year
participation questionnaire that examine the level of engagement in different occupations
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2017年7月1日

初级完成 (预期的)

2018年7月1日

研究完成 (预期的)

2018年8月1日

研究注册日期

首次提交

2017年4月1日

首先提交符合 QC 标准的

2017年5月6日

首次发布 (实际的)

2017年5月9日

研究记录更新

最后更新发布 (实际的)

2017年5月9日

上次提交的符合 QC 标准的更新

2017年5月6日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HaEmekAlon

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Virtual Reality - Virtual Interactive Supermarket的临床试验

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