A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207553
• Other study ID #: REC/FSD/0286
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

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	Lysholm Knee Scoring Scale	• 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
Primary	Kujala Anterior Knee Pain Scale	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
Primary	International Knee Documentation Committee Questionnaire	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