An observational study in Foot Deformity, Hallux Deformity and Assessment, Self, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Istanbul University - Cerrahpasa · Observational
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.
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.
50 studies on the registry are indexed under Foot Deformities; 13 are open to participants now.
This study's enrollment of 66 is below the median of 84 across 22 observational studies indexed under Foot Deformities.
Browse Foot Deformities studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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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.
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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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Ran from Jul 2021 to primary completion in Oct 2021, 3 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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