Validation of the American Orthopedic Foot and Ankle Society Midfoot Scale

Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246488
• Other study ID #: UBeykent-2
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: September 2022
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 27, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Foot

Intervention

Diagnostic Test:
• American Orthopedic Foot and Ankle Association Midfoot Scale, Foot and Ankle Ability Measure/FAAM, SF-12 Quality of Life Scale, Visual Analog Scale (VAS)
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 (VAS).

Locations

Country	Name	City	State
Turkey	Beykent University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
University of Beykent

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Analay Akbaba Y, Celik D, Ogut RT. Translation, Cross-Cultural Adaptation, Reliability, and Validity of Turkish Version of the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale. J Foot Ankle Surg. 2016 Nov - Dec;55(6):1139-1142. doi: 10.1053/j.jfas.2016.06.001. Epub 2016 Sep 7. — View Citation

Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. Review. — View Citation

Çelik D, Çoban Ö. Short Form Health Survey version-2.0 Turkish (SF-36v2) is an efficient outcome parameter in musculoskeletal research. Acta Orthop Traumatol Turc. 2016 Oct;50(5):558-561. doi: 10.1016/j.aott.2016.08.013. Epub 2016 Nov 17. — View Citation

Çelik D, Malkoç M, Martin R. Evidence for reliability, validity and responsiveness of Turkish Foot and Ankle Ability Measure (FAAM). Rheumatol Int. 2016 Oct;36(10):1469-76. doi: 10.1007/s00296-016-3485-4. Epub 2016 May 2. — View Citation

García Jiménez R, García-Gómez FJ, Noriega Álvarez E, Calvo Morón C, Martín-Marcuartu JJ. Hybrid imaging in foot and ankle disorders. Rev Esp Med Nucl Imagen Mol (Engl Ed). 2018 May - Jun;37(3):191-202. doi: 10.1016/j.remn.2017.10.003. Epub 2017 Dec 6. Review. English, Spanish. — View Citation

Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. — View Citation

Kostuj T, Krummenauer F, Schaper K, Stief F, Zettersten K, Baums MH, Meurer A, Lieske S. Analysis of agreement between the German translation of the American Foot and Ankle Society's Ankle and Hindfoot Scale (AOFAS-AHS) and the Foot Function Index in its validated German translation by Naal et al. (FFI-D). Arch Orthop Trauma Surg. 2014 Sep;134(9):1205-10. doi: 10.1007/s00402-014-2046-0. Epub 2014 Jul 11. — View Citation

Leigheb M, Janicka P, Andorno S, Marcuzzi A, Magnani C, Grassi F. Italian translation, cultural adaptation and validation of the "American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot scale". Acta Biomed. 2016 May 6;87(1):38-45. — View Citation

Reed MD, Van Nostran W. Assessing pain intensity with the visual analog scale: a plea for uniformity. J Clin Pharmacol. 2014 Mar;54(3):241-4. doi: 10.1002/jcph.250. Epub 2014 Jan 23. — View Citation

Vosoughi AR, Roustaei N, Mahdaviazad H. American Orthopaedic Foot and Ankle Society ankle-hindfoot scale: A cross-cultural adaptation and validation study from Iran. Foot Ankle Surg. 2018 Jun;24(3):219-223. doi: 10.1016/j.fas.2017.02.007. Epub 2017 Feb 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Association Midfoot Scale	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
Primary	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 carried out.	through study completion, an average of 6 months
Secondary	S-12 Quality of Life Scale	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
Secondary	Visual Analog Scale (VAS)	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