- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221060
Urdu Version of Kujala Questionnaire: A Reliability and Validity Study
March 8, 2022 updated by: Riphah International University
Reliability and Validity Study of Urdu Version of Kujala Questionnaire
The aim of this research is to interpret and make Kujala Questionnaire adaptable culturally into Urdu to investigate its validity and reliability in Pakistani population among anterior knee pain or patello femoral knee pain.
Also check its correlation with 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form.
Study Overview
Status
Completed
Detailed Description
The original English version of Kujala Questionnaire will be translated and culturally adapted as per previous recommendation.
In patients with anterior knee pain or patella femoral knee pain, Kujala Questionnaire-Urdu will be distributed among hundred 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 Kujala, 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form 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 (re-testing), for intra-observer assessment.
Data will be entered and analyzed Cronbach alpha value.
Test-retest reliability will be assessed using an intraclass correlation coefficient.
Urdu Version of Kujala was evaluated for content validity, construct validity, criterion validity and responsiveness.
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
-
-
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
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pakistani population with patello femoral pain syndrome and anterior knee pain.
Description
Inclusion Criteria:
- Both genders
- Ages range from 18-40 years
- They have clinically diagnosed with patello femoral pain syndrome (the diagnosis was established by a positive patellar grind test and pain on touch sensation, found in medial and lateral patellar facets)
- Participants who acquire 40 to 80 score on Kujala patellofemoral questionnaire before the treatment start
- Patients willing to participate.
Exclusion Criteria:
- Participants of the study who has gone through any treatment protocol curative measure for patellofemoral pain syndrome during the last 3 months.
- Any indication or medical record of lower extremity fracture or surgical procedure
- History of certain chronic disease e.g. Diabetes Mellitus
- Participants unable to understand Urdu Version of Kujala
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 |
---|---|---|
Kujala Questionnaire
Time Frame: 1st day
|
The Kujala Score is mainly used for the patients with anterior knee pain specially patients with patellofemoral pain syndrome that compromises of 13 questions asking about limping, supporting, walking , stairs descent and ascent movement, squat performance, running , jumping , sitting for a long time with flexed knee, pain intensity, swelling around joint, abnormally random knee cap movement that is also called as subluxation of patella ,weakness and atrophy of thigh muscles and lastly about the deficiencies that occurs during flexion movement.
Kujala Score ranges from 0 to 100 .The lowest the score, the greater the severity of functional limitations and pain intensity and vice versa.
|
1st day
|
36-Item Short Form Health Survey Questionnaire
Time Frame: 1st day
|
36-Item Short Form Health Survey questionnaire that is self-administered and is largely used for overall health condition and assessment moreover widely used for research purpose.
It contains 36 questions, including almost all basic 8 domains like; physical functioning, limitations due to the physical problems, bodily pain, general health perception, social functioning, vitality, limitations due to emotional problems, overall mental health and one more question about any health transition occurred in the last few days.
Score ranges from up to 100, higher score means higher level of perfection of general health a low score means the increase level of functional deficit
|
1st day
|
The Lysholm Score
Time Frame: 1st day
|
The Lysholm Score is one of the most common questionnaire used for assessment of severity of pain and level of functional limitations in patients with patellofemoral pain syndrome.
The point of concern are the ligaments Injury or mishap to ligament of the knee.
Higher scores indicate a better outcome with fewer symptoms or disability.
|
1st day
|
International Knee Documentation Committee Subjective Knee Evaluation Form
Time Frame: 1st day
|
The International Knee Documentation Committee was formulated in 1987 as an International documentation system for knee deficits.
Consisting 18 items out which 7 for symptoms, 1 for sports participation, 9 items for Activities of Daily Livings and lastly 1 for the current knee situation and function.
Possible scoring ranges from 0 to 100, the greater the score the greater the functional capability, lower the score the increase chances of symptoms.
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Muhammad Kashif, 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)
May 30, 2021
Primary Completion (ACTUAL)
February 10, 2022
Study Completion (ACTUAL)
February 15, 2022
Study Registration Dates
First Submitted
February 1, 2022
First Submitted That Met QC Criteria
February 1, 2022
First Posted (ACTUAL)
February 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 10, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-0239
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.
Clinical Trials on Patellofemoral Pain Syndrome
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
Laval UniversityCompletedPatellofemoral Pain (PFPS)Canada
-
Nationwide Children's HospitalCompletedPatellofemoral Pain Syndrome | Knee Pain Chronic | Anterior Knee Pain Syndrome | Patellofemoral SyndromeUnited States
-
University of MelbourneNational Health and Medical Research Council, AustraliaCompletedKnee Pain | Patellofemoral PainAustralia
-
Istanbul Medipol University HospitalCompletedPatellofemoral Pain Syndrome | Patellofemoral Pain | Anterior Knee Pain Syndrome | Patellofemoral Syndrome | Kinesiotape | Orthotic DevicesTurkey
-
Universidade Federal do CearaNot yet recruitingPatellofemoral Pain SyndromeBrazil
-
University of Central LancashireCompletedPatellofemoral PainUnited Kingdom
-
Universidade Federal do CearaCompletedPatellofemoral Pain SyndromeBrazil
-
European University CyprusCompleted
-
Universidade Federal do Rio Grande do NorteUnknown