- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05440500
Reliability and Validity of Urdu Translation of Western Ontario Shoulder Instability Index
January 13, 2023 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
90
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
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International university
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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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population of Pakistanis with shoulder instability will be included in the study.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1st day
|
|
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.
|
1st day
|
|
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.
|
1st day
|
|
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.
|
1st day
|
|
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".
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 20, 2022
Study Completion (Actual)
July 20, 2022
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/FSD/0291
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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