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临床试验/NCT02330198
NCT02330198已完成不适用

Evidence for Validity and Reliability of the Finnish Version of the Foot and Ankle Ability Measure

Turku University Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年3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
84
试验地点
1
主要终点
Modified American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score

研究概览

简要总结

The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.

详细描述

The aim of this study is to translate and adapt The Foot and Ankle Ability Measure tool (FAAM) in Finnish language and to evaluate the validity and reliability of the Finnish version of the Foot and ankle ability measure tool (FAAM-Fi).

This study is prospective. It is done by interviewing the patients to gather self-reported information of about their ability to perform different activities of daily living and sports. The study has no consequence to the patients, nor to the treatment aimed to solve the problem. This study includes cross-cultural adaptation of the FAAM to Finnish language and validation of the Finnish version of the FAAM.

The forward translation will be done with the method of used by the American Association of Orthopedic Surgeons (AAOS) Outcomes Committee. Two native Finnish-speakers and fluent in English translators, T1 and T2, translate the original version of the FAAM to Finnish language. T1 is aware of the items being examined in in the questionnaire being translated, but not a healthcare professional. T2 is so called naïve translator. A synthesis of T1 and T2 versions, T-12, is conducted under the supervision of a medical linguistic methodologist. The T-12 version is translated back to English by two native, English as their mother tongue speaking translators BT1 and BT2, neither aware nor informed of the items explored nor with medical background.

An expert committee (the medical linguistic professional, the investigator as an orthopedic specialist and the translators) consolidate all the versions and consider the pre-final version of the questionnaire. The expert committee will be in close contact with developers.

The pre-final version is pre-tested with 40 persons with foot and ankle disorders. They will complete the questionnaire and will be interviewed about the meaning of the questions and the response in order to ensure that the adapted version is retaining its equivalence in an applied situation. Possible missing responses are looked for. The last step is submitting the final version, the FAAM-Fi and all the written reports to the committee keeping track of the translated version and the developers of the final version.

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

  • Foot and ankle patients who will receive either conservative or operative treatment will be included. Mother language of the patients is Finnish.

排除标准

  • Age under 18 or denial of the patient.

结局指标

主要结局

Modified American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score

时间窗: 3 months

次要结局

  • 15 D instrument questionnaires(3 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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