NCT07729306

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

sports injuryshoulder painelbow pain

Outcome Measures

Primary Outcomes (2)

  • 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)).

    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).

    4 weeks

Interventions

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: 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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study will be conducted on 100 symptomatic Egyptian overhead athletes. They will be screened for inclusion and exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Elbow InjuriesAthletic InjuriesShoulder Pain

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

June 1, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations