UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049517 |
|---|---|
| Receipt number | R000056362 |
| Scientific Title | Characteristics of shoulder joint function in adolescent volleyball players. |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2024/02/06 19:34:53 |
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Basic information
Public title
Characteristics of shoulder joint function in adolescent volleyball players.
Acronym
Characteristics of shoulder joint function in adolescent volleyball players.
Scientific Title
Characteristics of shoulder joint function in adolescent volleyball players.
Scientific Title:Acronym
Characteristics of shoulder joint function in adolescent volleyball players.
Region
| Japan |
Condition
Condition
Functional disability of shoulder joint
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of shoulder joint function in adolescent volleyball players.
Basic objectives2
Others
Basic objectives -Others
To measure shoulder joint range of motion, shoulder rotator strength, shoulder joint dynamic stability, shoulder joint positioning sense, and acromio-humeral distance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shoulder joint range of motion, shoulder rotator strength, shoulder joint dynamic stability, shoulder joint positioning sense, and acromio-humeral distance.
Key secondary outcomes
Prevalence of glenohumeral joint internal rotation deficit, correlations between primary outcomes, relationship between primary outcomes and shoulder pain and court position, and sex differences.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
High school volleyball player in Saitama Prefecture, Japan.
Key exclusion criteria
(1) Those who cannot give their consent to participate in this study.
(2) Those who have ever experienced orthopedic surgery of the limbs or trunk.
(3) Those who have ever experienced dislocation of the GH joint.
(4) Those who currently have structural abnormalities of the shoulder or thorax, such as scoliosis or kyphosis.
(5) Those who are currently absent from club activities due to shoulder injuries.
(6) Those who are currently suspected of having subacromial impingement syndrome or instability of the GH joint.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama medical university
Division name
School of physical therapy, faculty of health and medical care
Zip code
3500496
Address
981 Kawakado, Moroyama, Iruma, Saitama, Japan
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Mizoguchi |
Organization
Saitama medical university graduate school
Division name
Medicine
Zip code
3500496
Address
981 Kawakado, Moroyama, Iruma, Saitama, Japan
TEL
049-295-1001
Homepage URL
yassunnyassunn@gmail.com
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Saitama Medical University
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
Tel
0492762143
rinri@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
108
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056362
