Instability, JointNCT05440500
Reliability and Validity of Urdu Translation of Western Ontario Shoulder Instability Index
An observational study of Instability, Joint, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this study is to translate Western Ontario Shoulder Instability Index into Urdu and test its authenticity and coherence among the Pakistani community with Shoulder instability. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Instability, Joint
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 20 Jul 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The population of Pakistanis with shoulder instability will be included in the study.
Who may be able to join
- Male and Female both patients.
- Pursuing one or more incidences of dislocation, with or without surgical stabilization.
- Participants with glenohumeral joint instabilities.
- Patients between the ages of 20 and 60 who are interested in participating.
Who cannot join
- History or presence of ;
- The presence of a disease other than the shoulder (osseous, tendinous, vascular,
- inflammatory, radicular, muscular, and so on).
- Shoulder surgery except perhaps surgical stabilization.
- The patient's unwillingness to engage in the study, as well as his or her lack of understanding or fill the questionnaires.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Reliability and Validity Study of Urdu Translation of Western Ontario Shoulder Instability Index in Patients With Shoulder Instability
The goal of this study is to translate Western Ontario Shoulder Instability Index into Urdu and test its authenticity and coherence among the Pakistani community with Shoulder instability.
Also check its correlation with Disability of Arm, Shoulder, and Hand Questionnaire, Rowe score , Walch-Duplay score and Visual Analogue Scale.
Read the detailed description
The original English version of the Western Ontario Shoulder Instability Index will be translated and culturally adapted .Among Shoulder Instability population, Western Ontario Shoulder Instability Index will provided to 90 participants which will be choose through convenience sampling technique . This sampling method based on pre-defined inclusion and exclusion criteria .To check intra-observer reliability of the final Urdu Translation of Western Ontario Shoulder Instability Index, Disability of Arm, Shoulder, and Hand Questionnaire, Walch-Duplay score, Rowe score and Visual Analogue Scale questionnaires will be filled at the same day by two observers for test inter-observers assessment second application will be applied after 35 minutes of first application. Third assessment will be performed after seven days by first observer. Data will be entered and analyzed by using Statistical Package of Social Sciences Version 24 . Internal consistency will be analyzed with Cronbach's alpha value . Intra-class correlation coefficient will be used to check retest reliability. Urdu Translation of Western Ontario Shoulder Instability Index will be evaluated for content validity ,construct validity ,criterion validity and responsiveness.
- Conditions
- Instability, Joint
- Keywords
- Western Ontario Shoulder Instability Index, Urdu Version, Reliability, Validity, Shoulder Instability, Walch-Duplay Score
- Medical subject headings
- Joint Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability Index
Western Ontario Shoulder Instability Index is an instrument which is used to find out outcomes of shoulder instability treatment . These measures has been used in acute and rehabilitation settings The Western Ontario Shoulder Instability Index covers community based functional activities which are useful for the patients of shoulder instability . It consists of twenty one items related to pain and Activities of Daily Livings
Measured: 1st day
Rowe Score
The Rowe score was divided into two categories based on whether or not widespread ligament laxity was present. The Rowe score is divided into three categories: instability, range of motion, and function.
Measured: 1st day
Disabilities Of Arm, Hand & Shoulder Questionnaire
Disabilities Of Arm, Hand \& Shoulder Questionnaire is required for a thorough evaluation of diseases affecting various parts of the arm, as well as for research investigations. It consists of thirty Questions related to pain and Activities of Daily Livings.
Measured: 1st day
Walch-Duplay Score
To measure clinical result, the Walch-Duplay score, which was influenced by the Rowe rating scale, takes into consideration both subjective and objective data: stability, pain, sport level recovery, mobility. It is not self-administered. It consists of four questions for assessment.
Measured: 1st day
Visual Analogue Scale
The Visual Analogue Scale was created to represent the concept of a fundamental continuity. A Visual Analogue Scale is typically a straight stripe measuring 100 mm long, with word descriptions for each end. The patient draws a line through the spot on the line which they believe best describes their present state. The Visual Analogue Scale score is calculated by calculating in millimeters as from the line's left side to the point marked by that of the patient. It usually ranges from "0" indicating "no pain" to the "10" indicating "worst pain".
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 posted30 Jun 2022
- Study start30 May 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instability, JointStudies 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
- 90 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
- NCT05440500
- Sponsor's protocol ID
- REC/FSD/0291
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2022
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity Study of Urdu Translation of Western Ontario Shoulder Instability Index in Patients With Shoulder Instability
- ClinicalTrials.gov ID
- NCT05440500
- Acronym / sponsor ID
- REC/FSD/0291
- Conditions
- Instability, Joint
- Keywords
- Western Ontario Shoulder Instability Index, Urdu Version, Reliability, Validity, Shoulder Instability, Walch-Duplay Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 30 Jun 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 goal of this study is to translate Western Ontario Shoulder Instability Index into Urdu and test its authenticity and coherence among the Pakistani community with Shoulder instability.
Also check its correlation with Disability of Arm, Shoulder, and Hand Questionnaire, Rowe score , Walch-Duplay score and Visual Analogue Scale.
Detailed description
The original English version of the Western Ontario Shoulder Instability Index will be translated and culturally adapted .Among Shoulder Instability population, Western Ontario Shoulder Instability Index will provided to 90 participants which will be choose through convenience sampling technique . This sampling method based on pre-defined inclusion and exclusion criteria .To check intra-observer reliability of the final Urdu Translation of Western Ontario Shoulder Instability Index, Disability of Arm, Shoulder, and Hand Questionnaire, Walch-Duplay score, Rowe score and Visual Analogue Scale questionnaires will be filled at the same day by two observers for test inter-observers assessment second application will be applied after 35 minutes of first application. Third assessment will be performed after seven days by first observer. Data will be entered and analyzed by using Statistical Package of Social Sciences Version 24 . Internal consistency will be analyzed with Cronbach's alpha value . Intra-class correlation coefficient will be used to check retest reliability. Urdu Translation of Western Ontario Shoulder Instability Index will be evaluated for content validity ,construct validity ,criterion validity and responsiveness.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population of Pakistanis with shoulder instability will be included in the study.
Key inclusion criteria (4 listed)
- Male and Female both patients.
- Pursuing one or more incidences of dislocation, with or without surgical stabilization.
- Participants with glenohumeral joint instabilities.
- Patients between the ages of 20 and 60 who are interested in participating.
Key exclusion criteria (5 listed)
- History or presence of ;
- The presence of a disease other than the shoulder (osseous, tendinous, vascular,
- inflammatory, radicular, muscular, and so on).
- Shoulder surgery except perhaps surgical stabilization.
- The patient's unwillingness to engage in the study, as well as his or her lack of understanding or fill the questionnaires.
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
Western Ontario Shoulder Instability Index
Time frame: 1st day
Western Ontario Shoulder Instability Index is an instrument which is used to find out outcomes of shoulder instability treatment . These measures has been used in acute and rehabilitation settings The Western Ontario Shoulder Instability Index covers community based functional activities which are useful for the patients of shoulder instability . It consists of twenty one items related to pain and Activities of Daily Livings
Rowe Score
Time frame: 1st day
The Rowe score was divided into two categories based on whether or not widespread ligament laxity was present. The Rowe score is divided into three categories: instability, range of motion, and function.
Disabilities Of Arm, Hand & Shoulder Questionnaire
Time frame: 1st day
Disabilities Of Arm, Hand \& Shoulder Questionnaire is required for a thorough evaluation of diseases affecting various parts of the arm, as well as for research investigations. It consists of thirty Questions related to pain and Activities of Daily Livings.
Walch-Duplay Score
Time frame: 1st day
To measure clinical result, the Walch-Duplay score, which was influenced by the Rowe rating scale, takes into consideration both subjective and objective data: stability, pain, sport level recovery, mobility. It is not self-administered. It consists of four questions for assessment.
Visual Analogue Scale
Time frame: 1st day
The Visual Analogue Scale was created to represent the concept of a fundamental continuity. A Visual Analogue Scale is typically a straight stripe measuring 100 mm long, with word descriptions for each end. The patient draws a line through the spot on the line which they believe best describes their present state. The Visual Analogue Scale score is calculated by calculating in millimeters as from the line's left side to the point marked by that of the patient. It usually ranges from "0" indicating "no pain" to the "10" indicating "worst pain".
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 17 Jan 2023.
- 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 Instability, Joint, 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 4 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 17 Jan 2023. 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?
Western Ontario Shoulder Instability Index (time frame: 1st day). The study lists 5 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 17 Jan 2023.