The Turkish Version of the Shanghai Elbow Dysfunction Score

NCT04872205 | Completed

• 1 other identifier: 33
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Elbow Fracture; Stiffness of Elbow, Not Elsewhere Classified; Orthopedic Disorder; Assessment, Self

Keywords

Elbow; Reliability; Validity; Function; Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Shanghai Elbow Dysfunction Score (SHEDS)

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

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

  Baseline (First assessment)

• Mayo Elbow Performance Score (MEPS)

  Baseline (First assessment)

• Short Form-12 (SF-12)

  Baseline (First assessment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Elbow Fractures; Musculoskeletal Diseases; Fractures, Bone

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries

Study Officials

• Tansu Birinci, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 4, 2021
• Study Start: June 30, 2021
• Primary Completion: September 1, 2021
• Study Completion: March 7, 2022
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)