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临床试验/NCT06257862
NCT06257862进行中(未招募)不适用

Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
130
试验地点
1
主要终点
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)

研究概览

简要总结

The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation.

The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation

The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Danish speaking
  • MPFL-reconstructed

排除标准

  • 未提供

结局指标

主要结局

Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)

时间窗: Baseline

Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

Banff patella instability instrument (BPII 2.0)

时间窗: Baseline

Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

Kujala (Anterior Knee Pain Scale)

时间窗: Baseline, after 6-8 days

Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

International knee documentation committee (IKDC)

时间窗: Baseline

Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Lind

Professor, PhD, MD

Aarhus University Hospital

研究点 (1)

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