Anterior Cruciate Ligament InjuriesNCT05207553
A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.
An observational study of Anterior Cruciate Ligament Injuries, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 28 Feb 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pakistani population with anterior cruciate ligament injuries was included in the study.
Who may be able to join
- From17 years Old to 60 Years Old
- Presence of an Anterior Cruciate Ligament Injury or Ligament Repair
- No intervention between the test-retest assessments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
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.
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Lysholm Knee Scale, Anterior Cruciate Ligament Injuries, Knee disorders, Validity, Urdu Version, Reliability, Arthroscopic Knee
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start30 May 2021
- Primary completion25 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- NCT05207553
- Sponsor's protocol ID
- REC/FSD/0286
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2022
- Last updated
- 6 Jul 2022
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05207553
- Acronym / sponsor ID
- REC/FSD/0286
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Lysholm Knee Scale, Anterior Cruciate Ligament Injuries, Knee disorders, Validity, Urdu Version, Reliability, Arthroscopic Knee
- 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
- 25 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Jan 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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pakistani population with anterior cruciate ligament injuries was included in the study.
Key inclusion criteria (3 listed)
- From17 years Old to 60 Years Old
- Presence of an Anterior Cruciate Ligament Injury or Ligament Repair
- No intervention between the test-retest assessments.
Key exclusion criteria (4 listed)
- 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.
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
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.
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.
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.
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 6 Jul 2022.
- 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 Anterior Cruciate Ligament Injuries, 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 3 inclusion and 4 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 6 Jul 2022. 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?
Lysholm Knee Scoring Scale (time frame: 1st day). 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 6 Jul 2022.