Shoulder and Elbow InjuryAr-KJOCNCT07729306
TRANSLATION, ADAPTATION, VALIDATION AND RELIABILITY OF ARABIC VERSION OF KERLAN-JOBE ORTHOPAEDIC CLINIC SHOULDER AND ELBOW SCORE IN EGYPTIAN SYMPTOMATIC OVERHEAD ATHLETES
An observational study of Shoulder and Elbow Injury, run by Ziad Mohamed Mohamed Abdalla Haroun at 1 site in Egypt.
Trial summary
PURPOSE: To perform a cross-cultural adaption of the KJOC Shoulder and Elbow score into the Arabic language, then to test its validity and reliability. BACKGROUND: Shoulder and elbow injuries are highly prevalent among overhead and throwing athletes, particularly in sports such as baseball, handball, volleyball, and… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Shoulder and Elbow Injury
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Jul 2026
- How long will I take part?
- 1 Week
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will be conducted on 100 symptomatic Egyptian overhead athletes. They will be screened for inclusion and exclusion criteria.
Who may be able to join
- Male or female symptomatic athletes who participates in overhead sports (badminton, water polo, basketball, baseball, softball, handball, volleyball, or tennis) at least twice a week (Paraskevopoulos et al., 2024).
- Age ranges from 18 to 45 years old (Schulz et al., 2022).
- Non illiterate native Arabic speakers
Who cannot join
- History of upper limb injury or any other injury that prevents the athlete from actively participating in their sport (Sukanen et al., 2022).
- History of recent upper limb trauma, neuropathic pain, or surgery (Sasagawa et al., 2024).
- Asymptomatic athletes who participate in overhead sports
- Occurrence of a new injury during the study's reliability assessment interval (Sedighimehr, 2020).
- Surgery that prevents full sports participation
- Arabic speakers who are not native speakers.
- Being illiterate or unable to read Arabic.
- Visual or cognitive difficulties that make it difficult to read the questionnaire or take part in the interview.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE:
To perform a cross-cultural adaption of the KJOC Shoulder and Elbow score into the Arabic language, then to test its validity and reliability.
Read more
BACKGROUND:
Shoulder and elbow injuries are highly prevalent among overhead and throwing athletes, particularly in sports such as baseball, handball, volleyball, and tennis throwing. Accurate assessment of upper extremity function in this athletic population is essential for injury prevention, clinical decision-making, and monitoring return-to-sport outcomes.
The Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score is a sport-specific, patient-reported outcome measure (PROM) developed to evaluate functional performance, pain, and sport-related limitations in overhead athletes. It has been widely used and validated in several languages including Spanish, Germany, Japanese, and Greek; however, no validated Arabic version is currently available.
Simple literal translation is insufficient for patient-reported outcome measures. Instead, a structured process of translation, cultural adaptation, and comprehensive psychometric validation is required to ensure linguistic accuracy, conceptual equivalence, cultural relevance, and measurement reliability for Arabic-speaking athletes.
HYPOTHESES:
The study hypothesizes that the Arabic version of the KJOC shoulder and elbow score will demonstrate strong validity and reliability as an assessment tool for evaluating upper extremity function in symptomatic Arabic-speaking overhead athletes.
RESEARCH QUESTION:
Is the adapted Arabic version of the KJOC Shoulder and Elbow score valid and reliable for assessing upper extremity function in Egyptian symptomatic overhead athletes?
Read the detailed description
This study will use a Descriptive, Methodological Design (Cross-Cultural Adaptation).
Description of Research Methodology: The study will follow standard international guidelines for cross-cultural adaptation (e.g., Beaton et al.).
PHASE 1: CROSS-CULTURAL ADAPTATION
The process includes five stages:
- translation, 2) synthesis of translations, 3) back-translation to the original language, 4) committee analysis, and 5) pre-testing.
Forward Translation: Two independent translators (one medical, one naive) translate English to Arabic.
Synthesis: Merging translations into one Arabic version. Backward Translation: Translating the Arabic version back to English by two native translators.
Expert Committee Review: Reviewing all reports to reach a pre-final version. Pre-testing (Cognitive Debriefing): Testing the pre-final version on a pilot sample of athletes to ensure clarity and cultural relevance.
PHASE 2: VALIDATION AND RELIABILITY TESTING By comparing the KJOC-Arabic's concurrent validity to the Arabic DASH questionnaire and using statistical and discriminant analyses to determine its construct validity, the validity of the test will be thoroughly evaluated. Participants will complete the questionnaire twice over the course of one to two weeks in order to assess test-retest reliability. An Intraclass Correlation Coefficient (ICC) of more than 0.80 is the target. Lastly, the Cronbach's alpha-coefficient of the translated assessment tool will be determined to assess its internal consistency.
- Conditions
- Shoulder and Elbow Injury
- Being tested
- Questionnaire and Physical Exam
- Keywords
- sports injury, shoulder pain, elbow pain
- Medical subject headings
- Elbow Injuries, Athletic Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic test
This study will use a Descriptive, Methodological Design (Cross-Cultural Adaptation).
Description of Research Methodology: The study will follow standard international guidelines for cross-cultural adaptation (e.g., Beaton et al.).
PHASE 1: CROSS-CULTURAL ADAPTATION
The process includes five stages:
- translation, 2) synthesis of translations, 3) back-translation to the original language, 4) committee analysis, and 5) pre-testing.
Forward Translation: Two independent translators (one medical, one naive) translate English to Arabic.
Synthesis: Merging translations into one Arabic version. Backward Translation: Translating the Arabic version back to English by two native translators.
Expert Committee Review: Reviewing all reports to reach a pre-final version. Pre-testing (Cognitive Debriefing): Testing the pre-final version on a pilot sample of athletes to ensure clarity and cultural relevance.
PHASE 2: VALIDATION AND RELIABILITY TESTING By comparing the KJOC-Arabic's concurrent valid
What is being measured
The primary outcome is the main question the study is designed to answer.
The KJOC Shoulder and Elbow score
The KJOC Shoulder and Elbow score is used to evaluate the functional status of athletes with shoulder and elbow disorders (Appendix II) (Silva et al., 2024). The KJOC is a 10-item visual analogue scale questionnaire given to patients; lower scores indicate a lower function or performance level, while higher scores indicate a greater function or performance level. The total score, which ranges from 0 to 100 points, is determined by adding together each individual item (Alberta et al., 2010). The KJOC score is the most sensitive for distinguishing minor differences in a throwing athlete's performance (Domb et al., 2010). KJOC is valid (Spearman: KJOC and DASH sports module =- 0.8036, KJOC and DASH =-0.6933) and reliable (Cronbach alpha of 0.9, indicating a high level of inter-item reliability (Domb et al., 2010), ICC= 0.802 (Erickson et al., 2018)).
Measured: 4 weeks
Arabic version of DASH
The DASH is a 30-item self-report survey with 5-point Likert scales. The range of scores is 0 (no disability) to 100 (the most severe disability). It is a general non-specific PROM helpful for individuals with any upper limb musculoskeletal condition (Hudak et al., 1996). Items include 21 questions evaluating particular physical tasks (e.g., using a knife or turning a key), 5 items evaluating symptoms (e.g., pain, tingling), and 4 questions evaluating social functions (e.g., sleep and confidence) (David et al., 2022). DASH has been transculturally adapted to Arabic language (Alotaibi, 2010). The DASH-Arabic is a valid, responsive, and dependable upper extremity outcome measure (Alotaibi et al., 2016), (Appendix IV).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder and Elbow InjuryStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ziad Mohamed Mohamed Abdalla Haroun
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Ziad Mohamed Mohamed Abdalla Haroun, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729306
- Sponsor's protocol ID
- P.T.REC/012/006562
- Acronym
- Ar-KJOC
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSLATION, ADAPTATION, VALIDATION AND RELIABILITY OF ARABIC VERSION OF KERLAN-JOBE ORTHOPAEDIC CLINIC SHOULDER AND ELBOW SCORE IN EGYPTIAN SYMPTOMATIC OVERHEAD ATHLETES
- ClinicalTrials.gov ID
- NCT07729306
- Acronym / sponsor ID
- Ar-KJOC / P.T.REC/012/006562
- Conditions
- Shoulder and Elbow Injury
- Keywords
- sports injury, shoulder pain, elbow pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ziad Mohamed Mohamed Abdalla HarounUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 27 Jul 2026 (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.
PURPOSE:
To perform a cross-cultural adaption of the KJOC Shoulder and Elbow score into the Arabic language, then to test its validity and reliability.
BACKGROUND:
Shoulder and elbow injuries are highly prevalent among overhead and throwing athletes, particularly in sports such as baseball, handball, volleyball, and tennis throwing. Accurate assessment of upper extremity function in this athletic population is essential for injury prevention, clinical decision-making, and monitoring return-to-sport outcomes.
The Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score is a sport-specific, patient-reported outcome measure (PROM) developed to evaluate functional performance, pain, and sport-related limitations in overhead athletes. It has been widely used and validated in several languages including Spanish, Germany, Japanese, and Greek; however, no validated Arabic version is currently available.
Simple literal translation is insufficient for patient-reported outcome measures. Instead, a structured process of translation, cultural adaptation, and comprehensive psychometric validation is required to ensure linguistic accuracy, conceptual equivalence, cultural relevance, and measurement reliability for Arabic-speaking athletes.
HYPOTHESES:
The study hypothesizes that the Arabic version of the KJOC shoulder and elbow score will demonstrate strong validity and reliability as an assessment tool for evaluating upper extremity function in symptomatic Arabic-speaking overhead athletes.
RESEARCH QUESTION:
Is the adapted Arabic version of the KJOC Shoulder and Elbow score valid and reliable for assessing upper extremity function in Egyptian symptomatic overhead athletes?
Detailed description
This study will use a Descriptive, Methodological Design (Cross-Cultural Adaptation).
Description of Research Methodology: The study will follow standard international guidelines for cross-cultural adaptation (e.g., Beaton et al.).
PHASE 1: CROSS-CULTURAL ADAPTATION
The process includes five stages:
- translation, 2) synthesis of translations, 3) back-translation to the original language, 4) committee analysis, and 5) pre-testing.
Forward Translation: Two independent translators (one medical, one naive) translate English to Arabic.
Synthesis: Merging translations into one Arabic version. Backward Translation: Translating the Arabic version back to English by two native translators.
Expert Committee Review: Reviewing all reports to reach a pre-final version. Pre-testing (Cognitive Debriefing): Testing the pre-final version on a pilot sample of athletes to ensure clarity and cultural relevance.
PHASE 2: VALIDATION AND RELIABILITY TESTING By comparing the KJOC-Arabic's concurrent validity to the Arabic DASH questionnaire and using statistical and discriminant analyses to determine its construct validity, the validity of the test will be thoroughly evaluated. Participants will complete the questionnaire twice over the course of one to two weeks in order to assess test-retest reliability. An Intraclass Correlation Coefficient (ICC) of more than 0.80 is the target. Lastly, the Cronbach's alpha-coefficient of the translated assessment tool will be determined to assess its internal consistency.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted on 100 symptomatic Egyptian overhead athletes. They will be screened for inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Male or female symptomatic athletes who participates in overhead sports (badminton, water polo, basketball, baseball, softball, handball, volleyball, or tennis) at least twice a week (Paraskevopoulos et al., 2024).
- Age ranges from 18 to 45 years old (Schulz et al., 2022).
- Non illiterate native Arabic speakers
Key exclusion criteria (8 listed)
- History of upper limb injury or any other injury that prevents the athlete from actively participating in their sport (Sukanen et al., 2022).
- History of recent upper limb trauma, neuropathic pain, or surgery (Sasagawa et al., 2024).
- Asymptomatic athletes who participate in overhead sports
- Occurrence of a new injury during the study's reliability assessment interval (Sedighimehr, 2020).
- Surgery that prevents full sports participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamThis study will use a Descriptive, Methodological Design (Cross-Cultural Adaptation). Description of Research Methodology: The study will follow standard international guidelines for cross-cultural adaptation (e.g., Beaton et al.). PHASE 1: CROSS-CULTURAL ADAPTATION The process includes five stages: 1) translation, 2) synthesis of translations, 3) back-translation to the original language, 4) committee analysis, and 5) pre-testing. Forward Translation: Two independent translators (one medical, one naive) translate English to Arabic. Synthesis: Merging translations into one Arabic version. Backward Translation: Translating the Arabic version back to English by two native translators. Expert Committee Review: Reviewing all reports to reach a pre-final version. Pre-testing (Cognitive Debriefing): Testing the pre-final version on a pilot sample of athletes to ensure clarity and cultural relevance. PHASE 2: VALIDATION AND RELIABILITY TESTING By comparing the KJOC-Arabic's concurrent valid | Diagnostic test | – |
Primary outcome
The KJOC Shoulder and Elbow score
Time frame: 4 weeks
The KJOC Shoulder and Elbow score is used to evaluate the functional status of athletes with shoulder and elbow disorders (Appendix II) (Silva et al., 2024). The KJOC is a 10-item visual analogue scale questionnaire given to patients; lower scores indicate a lower function or performance level, while higher scores indicate a greater function or performance level. The total score, which ranges from 0 to 100 points, is determined by adding together each individual item (Alberta et al., 2010). The KJOC score is the most sensitive for distinguishing minor differences in a throwing athlete's performance (Domb et al., 2010). KJOC is valid (Spearman: KJOC and DASH sports module =- 0.8036, KJOC and DASH =-0.6933) and reliable (Cronbach alpha of 0.9, indicating a high level of inter-item reliability (Domb et al., 2010), ICC= 0.802 (Erickson et al., 2018)).
Arabic version of DASH
Time frame: 4 weeks
The DASH is a 30-item self-report survey with 5-point Likert scales. The range of scores is 0 (no disability) to 100 (the most severe disability). It is a general non-specific PROM helpful for individuals with any upper limb musculoskeletal condition (Hudak et al., 1996). Items include 21 questions evaluating particular physical tasks (e.g., using a knife or turning a key), 5 items evaluating symptoms (e.g., pain, tingling), and 4 questions evaluating social functions (e.g., sleep and confidence) (David et al., 2022). DASH has been transculturally adapted to Arabic language (Alotaibi, 2010). The DASH-Arabic is a valid, responsive, and dependable upper extremity outcome measure (Alotaibi et al., 2016), (Appendix IV).
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shoulder and Elbow Injury, run by Ziad Mohamed Mohamed Abdalla Haroun at 1 site in Egypt.
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 8 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 27 Jul 2026. 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 Egypt. 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?
The KJOC Shoulder and Elbow score (time frame: 4 weeks). The study lists 2 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 27 Jul 2026.