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临床试验/NCT02161172
NCT02161172已完成不适用

Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
1
主要终点
Mini-Mental State Examination

研究概览

简要总结

Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • 18 ~ 60 years old
  • Education: primary school and above, who could understand the content of psychological test
  • History of brain trauma
  • No taking of antipsychotic or any other drugs affecting central nervous system before the test
  • Glasgow coma score (GCS) was 13-15

排除标准

  • History of craniocerebral injury, brain disease, mental disease
  • With mental retardation
  • with other serious body diseases
  • History of drug and alcohol dependence
  • With color-blind or color weakness
  • Who had severe visual and auditory disorders after brain injury
  • Who failed or failed in completing the test effectively
  • With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage

结局指标

主要结局

Mini-Mental State Examination

时间窗: 6 months

MMSE includes seven factors, namely: the time orientation factor (5 points), place orientation (5 points), immediate memory (3 points), short-term memory (3 points), calculation capabilities (5 points), verbal expression, naming and repetition (4 points), speech reading and understanding (4 points), graphic depiction (1 points). The scales for the description of cognitive function impairment were grouped into three levels of education: illiteracy (17 points), primary school (20 points) and middle school (24 points). The one with score below average was considered with cognitive function impairment.

次要结局

  • Activity of daily living scale(6 months)

研究者

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

Hao Chen

Doctor

Shanghai 6th People's Hospital

研究点 (1)

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