Knee PainNCT05221047
A Reliability and Validity Study of Urdu Version of Knee Outcome Survey-Activities of Daily Living Scale
An observational study of Knee Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of this study is to translate Knee Outcome Survey-Activities of Daily Living Scale into Urdu language and to check the reliability and validity of the Knee Outcome Survey-Activities of Daily Living Scale in Urdu language for the general population of Pakistan Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Pain
- How many people
- 150 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pakistani population with knee osteoarthritis was included in the study.
Who may be able to join
- Ability to walk without assistive device
- proficiency in the Urdu language
- pain level of at least 30% on the visual analog scale
Who cannot join
- Other osteoarthropathies with a good history
- If you have a heart condition or are having trouble with your nerves
- A debilitating factor that lowers functional independence and activity levels
- A lower-extremity fracture within the previous six months of the research
- Other joint diseases include ligament, menisci, or patellofemoral issues, as well as severe non-osteoarthritic knee effusion or arthroplasty
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Translation and Validation Study of the Urdu Version of the Knee Outcome Survey-Activities of Daily Living Scale in Patients With Knee Osteoarthritis
The purpose of this study is to translate Knee Outcome Survey-Activities of Daily Living Scale into Urdu language and to check the reliability and validity of the Knee Outcome Survey-Activities of Daily Living Scale in Urdu language for the general population of Pakistan
Read the detailed description
Approximately 150 participants will be included in the study on the basis of inclusion and exclusion criteria. The English version of the Knee Outcome Survey-Activities of Daily Living Scale will be translated and culturally adapted as per as previous recommendations. In the general population with knee pain,Urdu version of the Knee Outcome Survey-Activities of Daily Living Scale will be distributed among general participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu version of Knee Outcome Survey-Activities of Daily Living Scale with Knee osteoarthritis outcome survey and Lysholm knee score will be filled within same day, by two observers and for the inter-observers assessment, with an interval of 30 minutes between the first and second application. Third assessment will carry out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value.Test-retest reliability will be assessed using interclass correlation coefficient.
- Conditions
- Knee Pain
- Keywords
- Knee Outcome Survey-Activities of Daily Living Scale, General Population, Cultural adaptation, Validity, Urdu Version, Reliability, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee outcome survey-Activities of daily living scale
Its purpose is to assess the knee's functional state in relation to disability and disease It is a self-reported tool for individuals with knee osteoarthritis. The Knee Outcome Survey is divided into two scales. We may use the Activities of Daily Living Scale to evaluate symptoms and limitations in daily living functions
Measured: 1st day
Knee osteoarthritis outcome scale
The Knee osteoarthritis outcome scale evaluates both the short- and long-term effects of knee injuries. Pain, other Symptoms, Function in Daily Living, Function in Sport and Recreation, and knee-related Quality of Life are among the 42 questions in five independently scored sub-scales.
Measured: 1st day
Lysholm knee scoring scale
The Lysholm knee scale has eight domains: limping, locking, pain, stair-climbing, support, instability, swelling, and squatting.A total score of 0 to 100 is generated, with 95 indicating an outstanding outcome, 84 suggesting a good result, 65 indicating a fair result, and 65 indicating a bad result. The Lysholm knee scale has been used to assess a wide range of knee problems.
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 posted2 Feb 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 Knee PainStudies 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
- 150 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
- NCT05221047
- Sponsor's protocol ID
- REC-FSD-00298
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 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
- Translation and Validation Study of the Urdu Version of the Knee Outcome Survey-Activities of Daily Living Scale in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05221047
- Acronym / sponsor ID
- REC-FSD-00298
- Conditions
- Knee Pain
- Keywords
- Knee Outcome Survey-Activities of Daily Living Scale, General Population, Cultural adaptation, Validity, Urdu Version, Reliability, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 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
- 2 Feb 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 purpose of this study is to translate Knee Outcome Survey-Activities of Daily Living Scale into Urdu language and to check the reliability and validity of the Knee Outcome Survey-Activities of Daily Living Scale in Urdu language for the general population of Pakistan
Detailed description
Approximately 150 participants will be included in the study on the basis of inclusion and exclusion criteria. The English version of the Knee Outcome Survey-Activities of Daily Living Scale will be translated and culturally adapted as per as previous recommendations. In the general population with knee pain,Urdu version of the Knee Outcome Survey-Activities of Daily Living Scale will be distributed among general participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu version of Knee Outcome Survey-Activities of Daily Living Scale with Knee osteoarthritis outcome survey and Lysholm knee score will be filled within same day, by two observers and for the inter-observers assessment, with an interval of 30 minutes between the first and second application. Third assessment will carry out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value.Test-retest reliability will be assessed using interclass correlation coefficient.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pakistani population with knee osteoarthritis was included in the study.
Key inclusion criteria (3 listed)
- Ability to walk without assistive device
- proficiency in the Urdu language
- pain level of at least 30% on the visual analog scale
Key exclusion criteria (5 listed)
- Other osteoarthropathies with a good history
- If you have a heart condition or are having trouble with your nerves
- A debilitating factor that lowers functional independence and activity levels
- A lower-extremity fracture within the previous six months of the research
- Other joint diseases include ligament, menisci, or patellofemoral issues, as well as severe non-osteoarthritic knee effusion or arthroplasty
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
Knee outcome survey-Activities of daily living scale
Time frame: 1st day
Its purpose is to assess the knee's functional state in relation to disability and disease It is a self-reported tool for individuals with knee osteoarthritis. The Knee Outcome Survey is divided into two scales. We may use the Activities of Daily Living Scale to evaluate symptoms and limitations in daily living functions
Knee osteoarthritis outcome scale
Time frame: 1st day
The Knee osteoarthritis outcome scale evaluates both the short- and long-term effects of knee injuries. Pain, other Symptoms, Function in Daily Living, Function in Sport and Recreation, and knee-related Quality of Life are among the 42 questions in five independently scored sub-scales.
Lysholm knee scoring scale
Time frame: 1st day
The Lysholm knee scale has eight domains: limping, locking, pain, stair-climbing, support, instability, swelling, and squatting.A total score of 0 to 100 is generated, with 95 indicating an outstanding outcome, 84 suggesting a good result, 65 indicating a fair result, and 65 indicating a bad result. The Lysholm knee scale has been used to assess a wide range of knee problems.
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
Related trials for Knee Pain
RecruitingObservational study
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
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RecruitingPhase 3
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
Osteoarthritis, Overweight or Obesity
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 Knee Pain, 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 5 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?
Knee outcome survey-Activities of daily living 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.