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临床试验/NCT05246488
NCT05246488已完成不适用

Reliability and Validity Study of the American Orthopedic Foot and Ankle Society Midfoot Scale

University of Beykent1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年7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
57
试验地点
1
主要终点
American Orthopedic Foot and Ankle Association Midfoot Scale

研究概览

简要总结

Today, one of the frequently used scales in the evaluation of foot problems is the American Orthopedic Foot and Ankle Association Scale. AOFAS has been prepared with the American society in mind and its original version is in English. This limits the application of AOFAS to non-English speaking patients. The aim of study is to investigate the cross-cultural adaptation, reliability and validity of the Turkish version of the AOFAS Midfoot Scale.

详细描述

Foot and ankle disorders are the most common disorders affecting the musculoskeletal system and greatly affect patients' quality of life. Due to the complex anatomy and function of the foot, accurate diagnosis is an important clinical problem, making it difficult to locate the source of pain with routine clinical examination. There are many scales developed in academic studies or clinical practices to help diagnose or to evaluate foot-ankle diseases and accompanying symptoms and conditions.

The American Orthopedic Foot and Ankle Score is one of the widely used clinical outcome measures specifically designed to examine the foot and ankle. It consists of four grading systems, with each system set up to study a different anatomical area. These are the ankle-hindfoot, midfoot, hallux-metatarsophalangeal-interphalangeal, and smaller metatarsophalangeal-interphalangeal joints. The scale, which includes objective and subjective items, was developed to assess pain, function and smoothness. The original version of AOFAS is in English, which limits its application to non-English speaking patients. Some parts of AOFAS have been translated and culturally adapted into Turkish, Italian, German and Persian. The Turkish translation and cultural adaptation of AOFAS was completed only for the Ankle-Back Foot Scale out of the four rating systems. In this study, aimed to investigate the translation, cross-cultural adaptation, reliability and validity of the Turkish version of the AOFAS Midfoot Scale.

Translation and Cultural Adaptation Translation and cross-cultural adaptation of the AOFAS Midfoot Scale. It will be carried out in 5 stages, in line with the stages proposed by . In the first stage, the scale will be translated into Turkish independently by 2 Turks who have a good command of English. In the second stage, both translations will be compared in terms of conceptual errors and consistency by a bilingual translator. In the third stage, after the agreement is reached on the first Turkish translation, 2 native English speakers with a good command of Turkish will separately translate the completed Turkish translation into English. The purpose of this work will not be disclosed to both translators and they will not have access to the original English version. In the fourth stage, the translated version of the AOFAS Midfoot Scale will be compared with the original English version of the AOFAS Midfoot Scale by a committee of a methodologist, a linguist and 4 translators. The committee will be asked to evaluate the 4 translations and compare the inconsistencies and finalize them for approval.

Evaluations All participants will receive two assessments, 7 days apart. After the demographic data of the patients are recorded with the form prepared by us, they will be evaluated with the AOFAS Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analogue Scale.

AOFAS Midfoot The validity and reliability scale prepared by the American Orthopedic Foot-Ankle Association consists of three sub-dimensions. Evaluations in pain, function, smoothness sections and total scores range from 0 to 100 points. High scores indicate severe deformity and low scores indicate milder deformity.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients over the age of 18
  • Patients who were operated for Lisfranc and midfoot tarsometatarsal pathologies
  • Patients who are followed up and treated in the orthopedic service
  • Having the ability to read and write Turkish
  • Those who agreed to participate in the study

排除标准

  • patients under the age of 18
  • Patients with nerve injury and peripheral neuropathy, sensory loss, neuromuscular pathological findings, infection, acute fractures in the lower extremities, and acute rheumatic disease
  • Patients who are followed up and treated in external centers

结局指标

主要结局

American Orthopedic Foot and Ankle Association Midfoot Scale

时间窗: through study completion, an average of 6 months

The validity and reliability scale prepared by the American Orthopedic Foot-Ankle Association consists of three sub-dimensions. Evaluations in pain, function, smoothness sections and total scores range from 0 to 100 points. High scores indicate severe deformity and low scores indicate milder deformity.

Foot and Ankle Usability Measure

时间窗: through study completion, an average of 6 months

FAAM is a 29-item questionnaire including 21-item activities of daily living and 8-item sports subscales. The maximum score of the 5-point Likert-type scale is 84 for activities of daily living and 32 points for the sports subscale. The total score varies between 0-100. A higher score corresponds to a higher level of function for both subscales. The validity and reliability study of the scale was carried out.

次要结局

  • S-12 Quality of Life Scale(through study completion, an average of 6 months)
  • Visual Analog Scale (VAS)(through study completion, an average of 6 months)

研究者

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

Yasemin Şahbaz

doctoral lecturer

University of Beykent

研究点 (1)

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