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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
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
Secondary ID [1] 297984 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sports related shoulder injuries 312397 0
sports related back injuries 312707 0
Condition category
Condition code
Injuries and Accidents 310957 310957 0 0
Other injuries and accidents
Musculoskeletal 310958 310958 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 314204 0
Early Detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 319767 0
Sport related shoulder-back injury and recurrent rate by a 10 min interview with a questionnaire which is designed for this study
Timepoint [1] 319767 0
Ever 2 weeks for a year.
Secondary outcome [1] 369455 0
Strength by hand-held dynamometer
Timepoint [1] 369455 0
Initiation of study and each 3 months during a year.
Secondary outcome [2] 370000 0
Range of motion by goniometer/ inclinometer
Timepoint [2] 370000 0
Initiation of study and each 3 months during a year.
Secondary outcome [3] 370001 0
Functional movement assessment by Y-balance test set
Timepoint [3] 370001 0
Initiation of study and each 3 months during a year.
Secondary outcome [4] 370004 0
Joint range of motion during movement by motion capture system
Timepoint [4] 370004 0
Initiation of study and each 3 months during a year.
Secondary outcome [5] 370097 0
Muscle activation by EMG sensor
Timepoint [5] 370097 0
Initiation of study and each 3 months during a year.
Secondary outcome [6] 370098 0
Foot pressure by F-scan
Timepoint [6] 370098 0
Initiation of study and each 3 months during a year.

Eligibility
Key inclusion criteria
Performing the loaded overarm sports more than 3 years and under regular training with coach more than a year.
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute pain/ injury
2. Cervical pathology
3. Neurological / systemic disease
4. Receiving and musculoskeletal surgery
5. Pregnant

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2019
Actual
5/10/2019
Date of last participant enrolment
Anticipated
Actual
13/05/2020
Date of last data collection
Anticipated
Actual
19/05/2020
Sample size
Target
92
Accrual to date
Final
92
Recruitment outside Australia
Country [1] 21407 0
Taiwan, Province Of China
State/province [1] 21407 0
Taipei

Funding & Sponsors
Funding source category [1] 302507 0
Government body
Name [1] 302507 0
Ministry of Science and Technology
Country [1] 302507 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yi-fen Shih
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.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 302415 0
None
Name [1] 302415 0
None
Address [1] 302415 0
None
Country [1] 302415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303163 0
Institutional Review Board of National Yang-Ming University
Ethics committee address [1] 303163 0
Ethics committee country [1] 303163 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 303163 0
25/02/2019
Approval date [1] 303163 0
24/09/2019
Ethics approval number [1] 303163 0
Getting the approval from IRB committee.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92702 0
Prof Yi-Fen Shih
Address 92702 0
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.
Country 92702 0
Taiwan, Province Of China
Phone 92702 0
+886, 2, 28267340
Fax 92702 0
+886, 2, 28201841
Email 92702 0
yfshih@ym.edu.tw
Contact person for public queries
Name 92703 0
Yi-Fen Shih
Address 92703 0
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.
Country 92703 0
Taiwan, Province Of China
Phone 92703 0
+886, 2, 28267340
Fax 92703 0
+886, 2, 28201841
Email 92703 0
yfshih@ym.edu.tw
Contact person for scientific queries
Name 92704 0
Yi-Fen Shih
Address 92704 0
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.
Country 92704 0
Taiwan, Province Of China
Phone 92704 0
+886, 2, 28267340
Fax 92704 0
+886, 2, 28201841
Email 92704 0
yfshih@ym.edu.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.