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临床试验/NCT05258695
NCT05258695已完成不适用

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

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tansu Birinci

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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