Clinical trial NCT05258695: The Turkish Version of the AOFAS Hallux MTP-IP
Official title: American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal-interphalangeal Joint Scale (AOFAS Hallux MTP-IP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Deformity
Hallux Deformity
Assessment, Self
Orthopedic Disorder
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)
timeFrame: Day 1
Secondary outcomes:
measure: The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)
timeFrame: Within a 5-to-7-day period after the first assessment (Day 1)
measure: The Manchester-Oxford Foot Questionnaire (MOXFQ)
timeFrame: Day 1
measure: Short Form-12 (SF-12)
timeFrame: Day 1
measure: Visual Analogue Scale (VAS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: