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临床试验/NCT03146364
NCT03146364Unknown不适用

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

HaEmek Medical Center, Israel0 个研究点目标入组 40 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Modified 4 item test

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Hospitalization patients

Experimental

patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

干预措施: Virtual Reality - Virtual Interactive Supermarket (Device)

Ambulatory patients

Experimental

patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

干预措施: Virtual Reality - Virtual Interactive Supermarket (Device)

结局指标

主要结局

Modified 4 item test

时间窗: through study completion, an average of 1 year

"buy" 4 items with budget constraints, using the VIS

次要结局

  • Revised Observed Tasks of Daily Living (OTDL-R)(through study completion, an average of 1 year)
  • Trail Making Test A & B (TMT)(through study completion, an average of 1 year)
  • Executive Function Performance Test (EFPT)(through study completion, an average of 1 year)
  • The positive and negative syndrome scale (PANSS)(through study completion, an average of 1 year)
  • Adults Subjective Assessment of Participation(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alon Reshef

Head of psychiatry

HaEmek Medical Center, Israel

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