跳至主要内容
临床试验/NCT02988206
NCT02988206已完成不适用

Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Hangzhou Normal University0 个研究点目标入组 21 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
主要终点
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer

研究概览

简要总结

In this study,researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).

详细描述

The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own name and face, are more effective to elicit the patient's response than that of non-self-referential stimuli.

The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.The rest assessments were performed following the standard protocol of CRS-R. The differences between functional use of the two types of objects was analyzed by Chi-square test.

Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the using of personalized objects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients in minimally conscious state;
  • patients with stable condition;
  • each patient has athletic ability to some extent.

排除标准

  • premorbid neurology antecedent;
  • patients in coma or vegetative state;
  • patients < 1 months after the acute brain injury.

结局指标

主要结局

The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer

时间窗: one week

次要结局

未报告次要终点

研究者

发起方
Hangzhou Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuxiao Sun

Undergraduate student

Hangzhou Normal University

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