跳至主要内容
临床试验/NCT04755049
NCT04755049已完成不适用

The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020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
入组人数
120
试验地点
1
主要终点
The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire

研究概览

简要总结

Background: The patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp) is one of the most validated and reliable assessment tools. This study aimed to establish a validated Chinese version of ASESp (ASESp-CH).

Methods: A clinical prospective study was performed. Following the guidelines of forward-backward translation and cross-cultural adaptation, a Chinese version of ASESp was established. Patients older than 18 years with shoulder disorders were included. Patients who could not complete test-retest questionnaires within the interval of 7-30 days and patients who received interventions were excluded. Intraclass correlation (ICC) was calculated for test- retest reliability, whereas internal consistency was determined by Cronbach value. Construct validity was evaluated by comparing the corresponding domains between the ASESp-CH and a validated Chinese version of 36-Item Short Form Health Survey (SF-36).

研究设计

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

入排标准

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

入选标准

  • [1] patients' age ≥ 18 years
  • [2] patients with clear insights
  • [3] patients with any shoulder disorders
  • [4] patients who are able to speak and write in Chinese
  • [5] patients who completed the questionnaires twice at an interval of 7 days to 30 days.

排除标准

  • [1] the patient could not complete all of ASESp-CH and SF-36 questionnaires
  • [2] the test-retest interval was less than 7 days or more than 30 days
  • [3] the patient received interventional procedures, such as shoulder injections or surgery, during the test-retest interval

结局指标

主要结局

The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire

时间窗: The questionaire was completed at 7 days before the index surgery.

American Shoulder and Elbow Surgeons (ASES) Assessment Form, ranging from 0-100. The higher score indicates better shoulder function.

次要结局

未报告次要终点

研究者

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

Kai-Lan Hsu

Attending physician

National Cheng-Kung University Hospital

研究点 (1)

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