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临床试验/NCT06164145
NCT06164145招募中不适用

Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
1
主要终点
Short Form 36

研究概览

简要总结

The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are

  1. What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors?
  2. Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.

详细描述

Cross-cultural adaptation of a subjective questionnaire is required for use in a different country, culture, and/or language. Although the majority of questionnaires were created in English-speaking nations, researchers must nonetheless take into account non-native populations in health studies, particularly when their omission could result in a systematic bias in studies of health care usage (Beaton et al., 2000). For the purpose of translating and culturally adapting, it is crucial to achieve equality between the target and original sources of the questionnaire.

As it relates to the authors' perspective, the Short Form 36 (SF-36) has not yet been translated and cross-culturally adapted to be used in Myanmar. As a result, the features of a Burmese version's reliability and validity among individuals with a history of stroke have not been studied in the previous research work. In addition, the questionnaire should also be tested for its responsiveness to provide clinical meaningful for health care professions. Therefore, the aim of this study is to develop a Burmese version of the SF-36 (SF-36-Burmese) according to translation and cross-cultural adaption guidelines and evaluate its reliability, validity, and responsiveness (i.e., the instrument's capacity to identify changes over time in the construct being assessed) and the minimum clinical important difference (MCID, ie., the smallest change in an outcome that a patient would perceive as clinically meaningful) among stroke survivors.

研究设计

研究类型
Observational
观察模型
Other
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

  • Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
  • Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi & Hamzat, 2014)
  • Ability to understand the study and respond to questions (on the Mini- Mental State Examination > 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
  • Stable medical conditions

排除标准

  • Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
  • Recurrent stroke
  • Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)
  • Participants who cannot understand Burmese language

结局指标

主要结局

Short Form 36

时间窗: Baseline-1 week-4th week

Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible) (Ware \& Sherbourne, 1992).

次要结局

  • Berg Balance Scale (BBS)(Baseline-1 week)
  • Global Rating of Change (GRC) Scale(Baseline-1 week-4th week)
  • Patient Reported Outcome Measurement System (PROMIS-29)(Baseline-1 week)
  • Barthel Index (BI)(Baseline-1 week)

研究者

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

Myitzu Khin

Principal Investigator

Khon Kaen University

研究点 (1)

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