Validation of the American Orthopedic Foot and Ankle Society Midfoot Scale

September 28, 2022 updated by: Yasemin Şahbaz, University of Beykent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Foot and Ankle Usability Measure 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 conducted.

S-12 Quality of Life Scale The SF-12 Quality of Life Scale is a scale to evaluate quality of life by taking 12 questions from 8 different sub-dimensions of the SF-36 Quality of Life Scale. The shorter the scale, the easier it is in terms of applicability. The scale has a different scoring method than the SF-36. In the short form SF-12, physical and mental component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. The validity and reliability study of the scale was conducted.

Visual Analog Scale, participants are asked to select the point where they feel pain on a 10-centimeter horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.

Statistical Method SPSS 25.0/Statistical Package for Social Sciences Inc; Chicago, IL, USA statistical program will be used in all statistical analyses. For all variables, mean±standard deviation and percent values will be presented within the scope of descriptive statistics. In the evaluation of test results, the level of significance will be considered as p<0.05. Measurement properties for the examined scales will be analyzed in terms of internal consistency, test-retest reliability, construct validity, floor and ceiling effects.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

40 patients who applied to Bakirkoy Dr. Sadi Konuk Training & Research Hospital Orthopedics and Traumatology Clinic between 15.02.2022 and 15.08.2022 and were operated due to midfoot pathologies will be included in the study.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopedic Foot and Ankle Association Midfoot Scale
Time Frame: 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.
through study completion, an average of 6 months
Foot and Ankle Usability Measure
Time Frame: 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.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S-12 Quality of Life Scale
Time Frame: through study completion, an average of 6 months
Developed by Ware et al., the SF-12 Quality of Life Scale is a scale to evaluate quality of life by taking 12 questions from 8 different sub-dimensions of the SF-36 Quality of Life Scale. The shorter the scale, the easier it is in terms of applicability. The scale has a different scoring method than the SF-36. In the short form SF-12, physical (SF12-PCS) and mental (SF12-MCS) component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability. The validity and reliability study of the scale was carried out.
through study completion, an average of 6 months
Visual Analog Scale (VAS)
Time Frame: through study completion, an average of 6 months
Participants are asked to select the point where they feel their pain on a 10-centimeter (cm) horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Investigators

  • Principal Investigator: assis.prof. Altuğ Duramaz, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
  • Principal Investigator: as.dr. Alican Koluman, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
  • Principal Investigator: as.dr. Mehmet Utku Çiftçi, ISTANBUL BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
  • Principal Investigator: assis.prof. Tansu Birinci, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UBeykent-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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