The Turkish Version of the AOFAS Hallux MTP-IP

NCT05258695 | Completed

• 1 other identifier: 35
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Deformity; Hallux Deformity; Assessment, Self; Orthopedic Disorder

Outcome Measures

Primary Outcomes (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.

  Day 1

Secondary Outcomes (4)

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

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

• The Manchester-Oxford Foot Questionnaire (MOXFQ)

  Day 1

• Short Form-12 (SF-12)

  Day 1

• Visual Analogue Scale (VAS)

  Day 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Tansu Birinci, PhD, PT

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: July 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: April 11, 2022
• Last Updated: October 8, 2024

Record last verified: 2022-04

Locations

TU (1)