Elbow FractureNCT04872205
The Turkish Version of the Shanghai Elbow Dysfunction Score
An observational study of Elbow Fracture and Stiffness of Elbow, Not Elsewhere Classified, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elbow Fracture, Stiffness of Elbow, Not Elsewhere Classified, Orthopedic Disorder
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 7 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, 34147
About this study
Official title: The Reliability and Validity of 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.
Read the 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.
- Conditions
- Elbow Fracture, Stiffness of Elbow, Not Elsewhere Classified, Orthopedic Disorder, Assessment, Self
- Keywords
- Elbow, Reliability, Validity, Function, Fracture
- Medical subject headings
- Elbow Fractures, Musculoskeletal Diseases, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (First assessment)
Secondary outcomes (4)
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.
Measured: Within a 3-to-5-day period after the first assessment (Second assessment)
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.
Measured: Baseline (First assessment)
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.
Measured: Baseline (First assessment)
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.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start30 Jun 2021
- Primary completion1 Sep 2021
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University - Cerrahpasa
- Investigators
- Tansu Birinci, PhD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872205
- Sponsor's protocol ID
- 33
- Status last verified
- Oct 2024
- First submitted
- 30 Apr 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score
- ClinicalTrials.gov ID
- NCT04872205
- Acronym / sponsor ID
- 33
- Conditions
- Elbow Fracture, Stiffness of Elbow, Not Elsewhere Classified, Orthopedic Disorder, Assessment, Self
- Keywords
- Elbow, Reliability, Validity, Function, Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
The Shanghai Elbow Dysfunction Score (SHEDS)
Time frame: Within a 3-to-5-day period after the first assessment (Second assessment)
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Baseline (First assessment)
Mayo Elbow Performance Score (MEPS)
Time frame: Baseline (First assessment)
Short Form-12 (SF-12)
Time frame: Baseline (First assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Related trials for Elbow Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
Recruiting
Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
Elbow Fractures
Recruiting
Clinical Outcomes Study of the Nexel Total Elbow
Elbow Joint Destruction, Post-traumatic Lesions
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tansu Birinci, PhD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Fracture and Stiffness of Elbow, Not Elsewhere Classified, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Shanghai Elbow Dysfunction Score (SHEDS) (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.