The Turkish Version of the Shanghai Elbow Dysfunction Score

Orthopedic Disorder Clinical Trial

Official title:

The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872205
• Other study ID #: 33
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate elbow function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties.

Description:

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties. Approximately seventy patients with elbow limitation will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 3-to-5-day period after the first assessment, the participants will complete the Turkish version of SHEDS (SHEDS-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the Turkish version of Mayo Elbow Performance Score, and Short Form-12 will be determined to check the validity. Responsiveness and floor and ceiling effects will be detected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 7, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged between 20 and 55 years
• Elbow fracture in the six months before the study
• Elbow limitation in flexion or extension
• Fractures should be managed with surgically
• Being able to follow simple instructions
• Being able to read and write in Turkish

Exclusion Criteria:

• Malunion or Nonunion Fracture
• The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
• Non-healing wound or infection
• Previously received physiotherapy for elbow limitation
• Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
• Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity

Related Conditions & MeSH terms

• Assessment, Self
• Elbow Fracture
• Musculoskeletal Diseases
• Orthopedic Disorder
• Stiffness of Elbow, Not Elsewhere Classified

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Shanghai Elbow Dysfunction Score (SHEDS)	The Shanghai Elbow Dysfunction Score (SHEDS) is composed of 12 items and developed in 3 parts: elbow motion capacities, elbow-related symptoms, and patient satisfaction level. The SHEDS is a comprehensive and valid scoring system to evaluate elbow function in patients with elbow stiffness.	Baseline (First assessment)
Secondary	The Shanghai Elbow Dysfunction Score (SHEDS)	The Shanghai Elbow Dysfunction Score (SHEDS) is composed of 12 items and developed in 3 parts: elbow motion capacities, elbow-related symptoms, and patient satisfaction level. The SHEDS is a comprehensive and valid scoring system to evaluate elbow function in patients with elbow stiffness. The cumulative score is ranged from 0 to 100, where the higher scores indicate an increased level of function.	Within a 3-to-5-day period after the first assessment (Second assessment)
Secondary	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.	Baseline (First assessment)
Secondary	Mayo Elbow Performance Score (MEPS)	Mayo Elbow Performance Score (MEPS) is designed to measure pain, stability, range of motion and the patient's ability to accomplish functional tasks, is one of the most commonly used physician based and joint-specific elbow rating system The cumulative MEPS score is ranged from 0 to 100, where the higher scores indicate an increased level of function.	Baseline (First assessment)
Secondary	Short Form-12 (SF-12)	Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.	Baseline (First assessment)