UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049257 |
|---|---|
| Receipt number | R000056099 |
| Scientific Title | Investigation of concussion injuries and disabilities in male high school rugby players |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2024/01/23 21:02:39 |
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Basic information
Public title
Investigation of concussion injuries and disabilities in male high school rugby players
Acronym
Investigation of concussion in male high school rugby players
Scientific Title
Investigation of concussion injuries and disabilities in male high school rugby players
Scientific Title:Acronym
Investigation of concussion in male high school rugby players
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will survey and examine concussion evaluation methods, symptoms, return-to-play programs, tackling methods, and parents' understanding of concussion by administering a questionnaire to male high school rugby players and their parents.
Basic objectives2
Others
Basic objectives -Others
Clarify whether the parent is aware of the child's concussion injury.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
questionnaire
Key secondary outcomes
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
| 20 | years-old | >= |
Gender
Male
Key inclusion criteria
A male high school rugby player and parents who belongs to the Kanto Association.
Key exclusion criteria
Those who do not agree to participate in this study.
Those who cannot obtain a response from the questionnaire.
Target sample size
410
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
Zip code
350-0496
Address
981 Kawakado. Moroyama. Iruma. Saitama.
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Kikuchi |
Organization
Saitama Medical University Graduate School of Medicine
Division name
Doctoral Program in Physical Therapy
Zip code
350-0496
Address
981 Kawakado. Moroyama. Iruma. Saitama.
TEL
049-295-1001
Homepage URL
y.kikuike1009@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
Saitama Medical University Ethics Review Committee
Address
39. Morohongou. Moroyama. Iruma. Saitama.
Tel
049-276-2143
ethics@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 | 12 | Month | 13 | 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
101
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 | 12 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | 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
Questionnaire survey
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056099
