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Trial registered on ANZCTR
Registration number
ACTRN12619000719134
Ethics application status
Approved
Date submitted
25/04/2019
Date registered
13/05/2019
Date last updated
10/03/2022
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Sports related shoulder-back injuries and movement control in loaded overarm sports - Finding risk factors for predicting sports related shoulder-back injuries
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Scientific title
Comparing patients with and without sports related shoulder-back injuries in loaded overarm sports for finding the risk predictors from functional movement assessment, muscle activation and kinematic data
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Secondary ID [1]
297984
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
sports related shoulder injuries
312397
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sports related back injuries
312707
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Condition category
Condition code
Injuries and Accidents
310957
310957
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0
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Other injuries and accidents
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Musculoskeletal
310958
310958
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Following evaluations will be performed by well-trained physiotherapies at the initiation of study and following up, each 3 months for a year, as pending risk factor for the sports related shoulder-back injury.
1. Strength: The strength of major muscles in loaded overarm sports, including bilateral biceps brachii, deltoid, trapezius, pectoris major, shoulder external rotator, latissimus dorsi, gluteus maximum, hamstring, quadriceps, hip abductor and hip rotator, will be measured by hand-held dynamometer, and finished in 30 min.
2. Range of motion: All direction of movement in injury-related joints, bilateral shoulder, hip, knee, ankle, and thoracic, lumbar spine, will be measured by goniometer/ inclinometer. These measurement may take 15 min.
3. Functional movement assessment: Y-balance test for upper limb and functional movement screening (FMS). These measurement may take 30 min.
4. Kinematics, muscle activation and foot pressure: The kinematic data, muscle activation and foot pressure will be recorded when performing loaded overarm sports. For the kinematic variables, there include joint movement of bilateral shoulder, hip, knee, ankle and thoracic, lumbar spine. The electromyography will measurement in the injured side, which include biceps brachii, deltoid, upper and lower trapizeus, erector spinus, gluteus maximum, quadriceps and semitendinosus. A pair of foot pressure insole will put inside shoes during test. These measurement procedure may take a hour.
In the first phase, the sports related shoulder-back injuries in a past year will be record retrospectively, and the results of initial evaluations will be used to recognize risk factor.
The second phase starts immediately after initial evaluation. The conditions of sports related shoulder-back injuries for each subject will be recognized from the interview by physiotherapies per 2 weeks and following up for a year.
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Intervention code [1]
314204
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Early Detection / Screening
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Comparator / control treatment
Subject who performed loaded overarm sports and without sports related shoulder/ back injuries are enrolled as the control group. The evaluation results of control group will be used to identify the risk predictors by comparing with the experimental group.
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Control group
Active
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Outcomes
Primary outcome [1]
319767
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Sport related shoulder-back injury and recurrent rate by a 10 min interview with a questionnaire which is designed for this study
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Assessment method [1]
319767
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Timepoint [1]
319767
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Ever 2 weeks for a year.
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Secondary outcome [1]
369455
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Strength by hand-held dynamometer
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Assessment method [1]
369455
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Timepoint [1]
369455
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Initiation of study and each 3 months during a year.
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Secondary outcome [2]
370000
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Range of motion by goniometer/ inclinometer
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Assessment method [2]
370000
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Timepoint [2]
370000
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Initiation of study and each 3 months during a year.
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Secondary outcome [3]
370001
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Functional movement assessment by Y-balance test set
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Assessment method [3]
370001
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Timepoint [3]
370001
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Initiation of study and each 3 months during a year.
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Secondary outcome [4]
370004
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Joint range of motion during movement by motion capture system
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Assessment method [4]
370004
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Timepoint [4]
370004
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Initiation of study and each 3 months during a year.
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Secondary outcome [5]
370097
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Muscle activation by EMG sensor
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Assessment method [5]
370097
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Timepoint [5]
370097
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Initiation of study and each 3 months during a year.
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Secondary outcome [6]
370098
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Foot pressure by F-scan
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Assessment method [6]
370098
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Timepoint [6]
370098
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Initiation of study and each 3 months during a year.
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Eligibility
Key inclusion criteria
Performing the loaded overarm sports more than 3 years and under regular training with coach more than a year.
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Minimum age
15
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Acute pain/ injury
2. Cervical pathology
3. Neurological / systemic disease
4. Receiving and musculoskeletal surgery
5. Pregnant
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/10/2019
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Actual
5/10/2019
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Date of last participant enrolment
Anticipated
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Actual
13/05/2020
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Date of last data collection
Anticipated
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Actual
19/05/2020
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Sample size
Target
92
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Accrual to date
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Final
92
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Recruitment outside Australia
Country [1]
21407
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Taiwan, Province Of China
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State/province [1]
21407
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Taipei
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Funding & Sponsors
Funding source category [1]
302507
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Government body
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Name [1]
302507
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Ministry of Science and Technology
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Address [1]
302507
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106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
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Country [1]
302507
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Taiwan, Province Of China
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Primary sponsor type
Individual
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Name
Yi-fen Shih
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Address
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang Ming Chiao Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
302415
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None
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Name [1]
302415
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None
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Address [1]
302415
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None
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Country [1]
302415
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303163
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Institutional Review Board of National Yang-Ming University
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Ethics committee address [1]
303163
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No. 155, Li-Nong Street Section 2, Pei-Tou District, Institutional Review Board of National Yang Ming Chiao Tung University Taipei, Taiwan 112.
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Ethics committee country [1]
303163
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
303163
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25/02/2019
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Approval date [1]
303163
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24/09/2019
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Ethics approval number [1]
303163
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Getting the approval from IRB committee.
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Summary
Brief summary
Background and purpose: Shoulder and back injuries are the most common injury segments in loaded overarm sports, such as weightlifting. However, the associated risk factors and injury prevention have never been explored in the previous studies. Therefore we would like to hold a study to firstly determine the association between the musculoskeletal characteristics/ motor control performance and the weightlifting related shoulder-back injuries Methods: This study is divided into two phases: the first phase is an exploratory, correlational study, and the second phase is a prospective, longitudinal cohort study. For the first phase, we plan to recruit 30 collegiate/ high school students who have participated in weightlifting activities for more than three years, and have had repeated shoulder or back injury histories to be recruited in the injured group. 30 students have no chronic shoulder or back problems will be recruited as the control group. The demographic data will be collected, followed by measurement of musculoskeletal characteristics and motor control performance of the shoulder and back. Afterwards, the measurement of kinematics and muscle activation of the shoulder, trunk, hip, knee, and ankle, and foot pressure will be carried out during the snatch task. The relationship between the musculoskeletal and motor control characteristics and shoulder and back injuries is then assessed and associated factors are identified. After the baseline assessment, participants enter the second phase of the study and are followed for 12 months to record the injury incidence and severity and repeat the clinical assessment every three months. The potential risk factors are calculated to identify the predictors for the shoulder and back injuries.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
92702
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Prof Yi-Fen Shih
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Address
92702
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang Ming Chiao Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92702
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Taiwan, Province Of China
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Phone
92702
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+886, 2, 28267340
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Fax
92702
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+886, 2, 28201841
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Email
92702
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[email protected]
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Contact person for public queries
Name
92703
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Yi-Fen Shih
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Address
92703
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang Ming Chiao Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92703
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Taiwan, Province Of China
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Phone
92703
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+886, 2, 28267340
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Fax
92703
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+886, 2, 28201841
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Email
92703
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[email protected]
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Contact person for scientific queries
Name
92704
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Yi-Fen Shih
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Address
92704
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang Ming Chiao Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92704
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Taiwan, Province Of China
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Phone
92704
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+886, 2, 28267340
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Fax
92704
0
+886, 2, 28201841
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Email
92704
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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