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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Ripah International university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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