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临床试验/NCT06635395
NCT06635395已完成不适用

Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11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
42
试验地点
1
主要终点
Disability

研究概览

简要总结

The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society and to make its validity and reliability in Turkish. The BOSS was developed by Hameker et al to differentiate subscapularis tears from other rotator cuff muscle tears in patients with rotator cuff injuries. The BOSS has 5 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 25 participants will be included in the study. In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of the shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

详细描述

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.

The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of BOSS will be able to be modified. The data of BOSS will be collecting through face-to-face when the patients came to the rehabilitation center. 25 participants will be included in the study.

In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals over 18 years of age who have been diagnosed with a rotator cuff injury,
  • Patients whose native language is Turkish,
  • Individuals with a Mini Mental State Examination score of >24,

排除标准

  • Individuals with pain and disability due to any shoulder pathology other than rotator cuff injury,
  • Individuals who cannot read or write Turkish,
  • Individuals with shoulder fractures, surgical interventions and other accompanying shoulder pathologies,

结局指标

主要结局

Disability

时间窗: baseline

Disability will be assessed with the Baltimore Orthopedic Subscapularis Score (BOSS) in patients with rotator cuff injuries. It has 5 items. Each item is scored on a 1-to-5, a total score ranging from 5 (best possible score) to 25 (worst possible score). Higher scores indicate a higher disability.

Functionality of the shoulder

时间窗: baseline

Functionality of the shoulder will be assessed with the Western Ontario Rotator Cuff Disability Index (WORC) in patients with rotator cuff injuries. It has 21 items. Each item is scored on a 0-to-100-mm visual analog scale, summing a total score ranging from 0 (best possible score) to 2100 (worst possible score). Higher scores indicate poorer functionality.

次要结局

  • Health status(baseline)

研究者

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

Emel Mete

Research assistant

Istanbul Medeniyet University

研究点 (1)

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