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The Turkish Version of the Shanghai Elbow Dysfunction Score

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ClinicalTrials.gov Identifier: NCT04872205
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Tansu Birinci, Istanbul University-Cerrahpasa

Study Description
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Brief 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.

Condition or disease
Elbow Fracture Stiffness of Elbow, Not Elsewhere Classified Orthopedic Disorder Assessment, Self

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score
Actual Study Start Date : June 30, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : March 7, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants are patients who had sustained an elbow fracture and are treated surgically. The participants with elbow stiffness after an elbow fracture are directed for assessment following a confirmation by an orthopaedist that the bone fracture healed based on the physical examinations and diagnostic imaging.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872205


Locations
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Turkey
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, Turkey, 34147
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Tansu Birinci, PhD Istanbul Medeniyet University
More Information
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Responsible Party: Tansu Birinci, PT, PhD, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04872205    
Other Study ID Numbers: 33
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tansu Birinci, Istanbul University-Cerrahpasa:
Elbow
Reliability
Validity
Function
Fracture
Additional relevant MeSH terms:
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Musculoskeletal Diseases