Skip to main content
OpenTrials
Completed

NCT Number: NCT05258695

The Turkish Version of the 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Foot Deformity Assessment, Self Foot Deformities Hallux Deformity Musculoskeletal Diseases Orthopedic Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)

    Time frame: Day 1

    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.

Secondary outcomes

  1. The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)

    Time frame: Within a 5-to-7-day period after the first assessment (Day 1)

    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.

  2. The Manchester-Oxford Foot Questionnaire (MOXFQ)

    Time frame: Day 1

    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.

  3. Short Form-12 (SF-12)

    Time frame: Day 1

    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.

  4. Visual Analogue Scale (VAS)

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.