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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05440461
Other study ID # REC/FSD/0290
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date November 20, 2022

Study information

Verified date January 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- To translate the Oxford knee score into Urdu language - To evaluate the reliability and validity of Urdu Version of Oxford knee score for accessing pain and physical function in patients with knee osteoarthritis. - To evaluate the correlation of Oxford knee score with Western Ontario McMaster universities osteoarthritis index and International Knee Documentation Committee


Description:

The original English version of Oxford Knee Score will be translated and culturally adapted as per previous recommendation. In patients with knee osteoarthritis, Urdu Version of Oxford Knee Score will be distributed among 100 participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Oxford Knee Score will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1, for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient. Urdu Version of Oxford Knee Score will be evaluated for content validity, construct validity, criterion validity and responsiveness.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 20, 2022
Est. primary completion date November 20, 2022
Accepts healthy volunteers No
Gender All
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria: - Diagnosed knee Osteoarthritis patients were included - Both male and female patients were included - Both unilateral and bilateral knee Osteoarthritis patients were included - Patients were included who fulfilled the American college of rheumatology criteria - Patients were included between the age of 35-80 Y old patients Exclusion Criteria: - Patients with any heart problem were excluded - Patients with peripheral vascular injury were excluded

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxford knee score Oxford knee score is 12 items self-evaluation form which is used to evaluate the knee Osteoarthritis. Oxford knee score is used to evaluate pain and physical disability. day 1
Primary Western Ontario McMaster universities osteoarthritis index Western Ontario McMaster universities osteoarthritis index is a 24 items to evaluate knee Osteoarthritis. First 5 items are used to evaluate pain, 6 and 7 items are used to evaluate stiffness and next 8 to 24 questions are used to access physical function. day 1
Primary International Knee Documentation Committee International Knee Documentation Committee has 19 items. It is used to evaluate knee Osteoarthritis and ligament injuries. The International Knee Documentation Committee is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) day 1
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