The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study
1 other identifier
observational
120
1 country
1
Brief Summary
Background: The patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp) is one of the most validated and reliable assessment tools. This study aimed to establish a validated Chinese version of ASESp (ASESp-CH). Methods: A clinical prospective study was performed. Following the guidelines of forward-backward translation and cross-cultural adaptation, a Chinese version of ASESp was established. Patients older than 18 years with shoulder disorders were included. Patients who could not complete test-retest questionnaires within the interval of 7-30 days and patients who received interventions were excluded. Intraclass correlation (ICC) was calculated for test- retest reliability, whereas internal consistency was determined by Cronbach value. Construct validity was evaluated by comparing the corresponding domains between the ASESp-CH and a validated Chinese version of 36-Item Short Form Health Survey (SF-36).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedFirst Submitted
Initial submission to the registry
February 6, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 29, 2022
September 1, 2022
7 months
February 6, 2021
September 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
American Shoulder and Elbow Surgeons (ASES) Assessment Form, ranging from 0-100. The higher score indicates better shoulder function.
The questionaire was completed at 7 days before the index surgery.
Interventions
The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
Eligibility Criteria
patients with any shoulder disorders
You may qualify if:
- \[1\] patients' age ≥ 18 years
- \[2\] patients with clear insights
- \[3\] patients with any shoulder disorders
- \[4\] patients who are able to speak and write in Chinese
- \[5\] patients who completed the questionnaires twice at an interval of 7 days to 30 days.
You may not qualify if:
- \[1\] the patient could not complete all of ASESp-CH and SF-36 questionnaires
- \[2\] the test-retest interval was less than 7 days or more than 30 days
- \[3\] the patient received interventional procedures, such as shoulder injections or surgery, during the test-retest interval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 70428, Taiwan
Related Publications (1)
Tie TA, Hong CK, Chua I, Kuan FC, Su WR, Hsu KL. The Chinese version of the American shoulder and elbow surgeons standardized shoulder assessment form questionnaire, patient self-report section: a cross-cultural adaptation and validation study. BMC Musculoskelet Disord. 2021 Apr 24;22(1):382. doi: 10.1186/s12891-021-04255-z.
PMID: 33894753DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
February 6, 2021
First Posted
February 15, 2021
Study Start
March 1, 2020
Primary Completion
September 30, 2020
Study Completion
December 1, 2021
Last Updated
September 29, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share