- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05207553
A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.
July 4, 2022 updated by: Riphah International University
Validity and Test Re-test Reliability of the Urdu Version of Lysholm Knee Scoring Scale in Patients With Anterior Cruciate Ligament Injuries in the Pakistani Clinical Setting.
The study will be intended to translate and check if the Urdu Version of Lysholm Knee Scoring Scale is reliable and valid in the Pakistani patients with anterior cruciate ligament injuries.
Study Overview
Status
Completed
Conditions
Detailed Description
A detailed research will be conducted on nearly 100 patients after ethical approval from the Ethical Review Board of Riphah International University Faisalabad Campus.
A total of 100 patients with Anterior Cruciate Ligament injuries will be selected from different areas of community and rehabilitation centers.
Informed consent will be taken from each patient.
The tool will be used three times in the same Pakistani population with Anterior Cruciate Ligament injuries to check inter and intra-observer reliability of the final Urdu-LKS.
The Lysholm questionnaire translation will be carried out in 6 steps by the guidelines of the early researches and the Consensus-based Standards for the selection of health Measurement Instruments standard.
Statistical Package of Social Sciences 23 will be employed to do data analysis.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pakistani population with anterior cruciate ligament injuries was included in the study.
Description
Inclusion Criteria:
- From17 years Old to 60 Years Old
- Presence of an Anterior Cruciate Ligament Injury or Ligament Repair
- No intervention between the test-retest assessments.
Exclusion Criteria:
- To complete the forms because of a psychological Impairment.
- Illiteracy or lack of understanding of Urdu Language
- Had a condition that couldn't be settled after a second assessment for different sicknesses like cancer, any other serious Infection, or inflammatory disease
- The presence of neurologic or musculoskeletal disorders other than the knee Condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm Knee Scoring Scale
Time Frame: 1st day
|
• The Lysholm scale was developed for use by physicians and has been verified in patients with Anterior Cruciate Ligament and meniscal injuries.
It's also been approved as a patient-administered tool for assessing symptoms and function in people who have had a variety of knee injuries.
The Lysholm scale assesses the domains of symptoms and complaints, as well as functioning in daily activities, however, it doesn't assess the area of sports and recreational activities.
There are 8 items on this questionnaire and graded on a scale of 0 to 100, with higher scores suggesting fewer symptoms and better function.
|
1st day
|
|
Kujala Anterior Knee Pain Scale
Time Frame: 1st day
|
Kujala Anterior Knee Pain Scale - a patient-reported evaluation of subjective symptoms and functional limitations in patients with patellofemoral diseases, was published.
Patients with anterior knee pain, patellar subluxation, and patellar dislocation, as well as a control group, were included in the initial study group for the score.
The Kujala questionnaire has 13 items totaling 100 points.
All 13 questions in the original 1993 study had statistically significant between-group differences.
|
1st day
|
|
International Knee Documentation Committee Questionnaire
Time Frame: 1st day
|
The IKDC is a patient-completed questionnaire that comprises sections on tibiofemoral joint physical signs (7 items), function (2 items), and sports activities (3 things) (2 items).
Scores vary from 0 to 100, with 0 being the lowest degree of function and 100 demonstrating the uppermost level of physical signs.
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2021
Primary Completion (Actual)
February 25, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/FSD/0286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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