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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258695
Other study ID # 35
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date April 11, 2022

Study information

Verified date April 2022
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date April 11, 2022
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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
Secondary 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
Secondary 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
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