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NCT Number: NCT04872205

The Turkish Version of the Shanghai Elbow Dysfunction Score

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.

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Key information

Conditions

Elbow Fracture Arm Injuries Assessment, Self Elbow Fractures Elbow Injuries Fractures, Bone Musculoskeletal Diseases Orthopedic Disorder Stiffness of Elbow, Not Elsewhere Classified Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Shanghai Elbow Dysfunction Score (SHEDS)

    Time frame: Baseline (First assessment)

    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.

Secondary outcomes

  1. The Shanghai Elbow Dysfunction Score (SHEDS)

    Time frame: Within a 3-to-5-day period after the first assessment (Second assessment)

    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.

  2. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    Time frame: Baseline (First assessment)

    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.

  3. Mayo Elbow Performance Score (MEPS)

    Time frame: Baseline (First assessment)

    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.

  4. Short Form-12 (SF-12)

    Time frame: Baseline (First assessment)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 4, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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