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

September 28, 2022 updated by: Kai-Lan Hsu, National Cheng-Kung University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 70428
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with any shoulder disorders

Description

Inclusion Criteria:

  • [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.

Exclusion Criteria:

  • [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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
Time Frame: The questionaire was completed at 7 days before the index surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-109-163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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