- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177302
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 3
Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(3)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al.
We translated the questionnaire from the English version involved following steps: (1)initial translation with two bilingual translators (2) holding consensus meeting for the preliminary Chinese version (3) back translation with other two bilingual back translators (4) another consensus meeting for ensuring the consistency with original English version (5) pretesting for wording and understanding (6) Wording, rephrasing and format corrected to obtain final Chinese version of the HAGOS.
The aim of the study is to determine the validity, reliability and responsiveness of HAGOS-C by recruiting young to middle-aged physically active individuals with long-standing hip and/ or groin pain.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Yi-Fen Shih, Ph.D
- Phone Number: +886-2-28267340
- Email: yfshih@nycu.edu.tw
Study Contact Backup
- Name: Teng-Kuan Cheng, B.S.
- Phone Number: +886-934283837
- Email: wunanmin.be09@nycu.edu.tw
Study Locations
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-
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Taipei, Taiwan, 11221
- National Yang Ming University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- physically active at least 2.5 hrs/week
- tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis
- hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint.
- pain lasting for 2 to 6 month and no obvious changes within 3 week recently.
Exclusion Criteria:
- other symptoms in lumbar, knee or ankle joint.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Individuals with hip and/ or groin pain
The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month.
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The subjects will be instructed to complete HAGOS-C at the initial contact and again after 1 week and 4 month for reliability and responsiveness test, respectively
The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAGOS-C
Time Frame: immediately after the intervention
|
The individuals will be asked to complete 37 items of the HAGOS-C after instruction
|
immediately after the intervention
|
SF-36v2
Time Frame: immediately after the intervention
|
The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation
|
immediately after the intervention
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HAGOS-C
Time Frame: after 1 week
|
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.
|
after 1 week
|
HAGOS-C
Time Frame: after 4 months
|
The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness
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after 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yi-Fen Shih, Ph.D, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YM110027E(3)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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