Knee OsteoarthritisNCT05440461
Reliability and Validity Study of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with knee Osteoarthritis were included from Pakistan
Who may be able to join
- 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
Who cannot join
- Patients with any heart problem were excluded
- Patients with peripheral vascular injury were excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis
- 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
Read the detailed 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.
- Conditions
- Knee Osteoarthritis
- Keywords
- Oxford Knee Score, Urdu Version, Reliability, Validity, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
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.
Measured: day 1
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)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start30 May 2021
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440461
- Sponsor's protocol ID
- REC/FSD/0290
- Status last verified
- Jan 2024
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05440461
- Acronym / sponsor ID
- REC/FSD/0290
- Conditions
- Knee Osteoarthritis
- Keywords
- Oxford Knee Score, Urdu Version, Reliability, Validity, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee Osteoarthritis were included from Pakistan
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with any heart problem were excluded
- Patients with peripheral vascular injury were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxford knee score
Time frame: day 1
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.
Western Ontario McMaster universities osteoarthritis index
Time frame: day 1
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.
International Knee Documentation Committee
Time frame: day 1
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford knee score (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.