- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06257862
Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)
Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Aarhus N, Denmark, 8200
- Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Danish speaking
- MPFL-reconstructed
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kujala (Anterior Knee Pain Scale)
Time Frame: Baseline, after 6-8 days
|
Patient reported outcome score.
(0-100 (0 = Worst, 100 = Best)
|
Baseline, after 6-8 days
|
|
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
Time Frame: Baseline
|
Patient reported outcome score.
(0-100 (0 = Worst, 100 = Best)
|
Baseline
|
|
International knee documentation committee (IKDC)
Time Frame: Baseline
|
Patient reported outcome score.
(0-100 (0 = Worst, 100 = Best)
|
Baseline
|
|
Banff patella instability instrument (BPII 2.0)
Time Frame: Baseline
|
Patient reported outcome score.
(0-100 (0 = Worst, 100 = Best)
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Questionnaire KUJALA-DK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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