The Turkish Version of the AOFAS Hallux MTP-IP

American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal-interphalangeal Joint Scale (AOFAS Hallux MTP-IP)

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate the pain, function and alignment in patients with hallux deformities. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Assessment, Self; Hallux Deformity; Foot Deformity

Detailed Description

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties. Approximately seventy patients with hallux deformities will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of AOFAS Hallux MTP-IP (AOFAS Hallux MTP-IP-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Manchester-Oxford Foot Questionnaire (MOXFQ) and Short Form-12 will be determined to check the validity.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Turkey
  • Bakırkoy
    • Istanbul, Bakırkoy, Turkey, 34147
      • Istanbul University-Cerrahpaşa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants are patients who have an hallux deformity and are treated in the orthopedic service. The participants with hallux deformity are directed for assessment following a confirmation by an orthopaedist based on the physical examinations and diagnostic imaging.

Description

Inclusion Criteria:

• Aged between 18 and 65 years
• Diagnosis of Hallux deformities
• Continuing follow-up and treatment in the orthopedic service
• Being able to follow simple instructions
• Being able to read and write in Turkish

Exclusion Criteria:

• Having any cardiovascular diseases, neurological disorders, rheumatic diseases, or psychiatric diseases
• Having peripheral nerve injury, peripheral neuropathy, or sensory loss in the lower extremity
• Having heterotopic ossification, myositis ossification, or post-traumatic ankylosing in the lower extremity
• Fracture, non-healing wound, or infection in the lower extremity

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)	The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is composed of 9 items, distributed over 3 categories: pain (40 points), functional aspects (50 points), and alignment (10 points), for a total of 100 points.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)	The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is composed of 9 items, distributed over 3 categories: pain (40 points), functional aspects (50 points), and alignment (10 points), for a total of 100 points.	Within a 5-to-7-day period after the first assessment (Day 1)
The Manchester-Oxford Foot Questionnaire (MOXFQ)	The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.	Day 1
Short Form-12 (SF-12)	Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.	Day 1
Visual Analogue Scale (VAS)	Pain intensity will be measured using the Visual Analogue Scale (VAS), in which the participants will be asked to indicate their perceived pain at rest, during activity, and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on a 10 cm line using a ruler.	Day 1

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Tansu Birinci, PhD, PT, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Congenital Abnormalities; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Congenital
• Other Study ID Numbers: 35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No