- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06635395
Turkish Validity and Reliability of Baltimore Orthopedic Subscapularis Score
Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of BOSS will be able to be modified. The data of BOSS will be collecting through face-to-face when the patients came to the rehabilitation center. 25 participants will be included in the study.
In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34000
- Istanbul Medeniyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals over 18 years of age who have been diagnosed with a rotator cuff injury,
- Patients whose native language is Turkish,
- Individuals with a Mini Mental State Examination score of >24,
Exclusion Criteria:
- Individuals with pain and disability due to any shoulder pathology other than rotator cuff injury,
- Individuals who cannot read or write Turkish,
- Individuals with shoulder fractures, surgical interventions and other accompanying shoulder pathologies,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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patients with Rotator cuff injury
Scale validity and reliability The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish.
It has 5 questions.
The patients will be sought to answer questionnaires during regular rehabilitation sessions.
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The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society in patients with rotator cuff injury and to make its validity and reliability in Turkish.
It has 5 questions.
The patients will be sought to answer questionnaires during regular rehabilitation sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disability
Time Frame: baseline
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Disability will be assessed with the Baltimore Orthopedic Subscapularis Score (BOSS) in patients with rotator cuff injuries.
It has 5 items.
Each item is scored on a 1-to-5, a total score ranging from 5 (best possible score) to 25 (worst possible score).
Higher scores indicate a higher disability.
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baseline
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Functionality of the shoulder
Time Frame: baseline
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Functionality of the shoulder will be assessed with the Western Ontario Rotator Cuff Disability Index (WORC) in patients with rotator cuff injuries.
It has 21 items.
Each item is scored on a 0-to-100-mm visual analog scale, summing a total score ranging from 0 (best possible score) to 2100 (worst possible score).
Higher scores indicate poorer functionality.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health status
Time Frame: baseline
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Health status will be assessed with the SF-12.
It has 12 items.
It has eight sub-dimensions and two summary scores: physical and mental.
In the total score obtained from the scale, 100 indicates the best health status, while 0 indicates the worst health status.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: emel mete, PhD, Istanbul Medeniyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOSS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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