Clinical trial NCT04872205: The Turkish Version of the Shanghai Elbow Dysfunction Score
Official title: The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elbow Fracture
Stiffness of Elbow, Not Elsewhere Classified
Orthopedic Disorder
Assessment, Self
Keywords: Elbow
Reliability
Validity
Function
Fracture
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The Shanghai Elbow Dysfunction Score (SHEDS)
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: The Shanghai Elbow Dysfunction Score (SHEDS)
timeFrame: Within a 3-to-5-day period after the first assessment (Second assessment)
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Baseline (First assessment)
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: Baseline (First assessment)
measure: Short Form-12 (SF-12)
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul Medeniyet University
name: Tansu Birinci, PhD
role: PRINCIPAL_INVESTIGATOR
References: