UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061240 |
|---|---|
| Receipt number | R000070067 |
| Scientific Title | The Relationship Between Head Impact Exposure and Playing Characteristics in Male Soccer Players |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/13 10:01:26 |
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Basic information
Public title
A Study of Head Impacts and Playing Characteristics in Male Soccer Players
Acronym
A Study of Head Impacts and Playing Characteristics in Male Soccer Players
Scientific Title
The Relationship Between Head Impact Exposure and Playing Characteristics in Male Soccer Players
Scientific Title:Acronym
The Relationship Between Head Impact Exposure and Playing Characteristics in Male Soccer Players
Region
| Japan |
Condition
Condition
Sports-related concussion
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantify head and body impacts during matches and training in male collegiate soccer players and to identify play characteristics associated with head impact risk through video analysis. Furthermore, by evaluating ocular motor function over time after matches and training and examining its association with impact exposure, this study aims to clarify the nature of head impacts in soccer and provide insights for prevention.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Head impact acceleration (G) measured using a mouthguard-based accelerometer during training and matches
Key secondary outcomes
Ocular motor function (Vergence SD) assessed after training and matches, on the following day, 1 week later, 1 month later, 3 months later, and 1 year later
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
| 18 | years-old | <= |
Age-upper limit
| 21 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male soccer players belonging to a university soccer team
2. Individuals who have received an explanation of the study and provided written informed consent
3. Individuals who are scheduled to participate in regular training sessions and matches during the measurement period
4. Individuals with no history of head injury within 3 months prior to enrollment
5. Individuals with no ophthalmologic disease that may interfere with ocular motor function assessment
Key exclusion criteria
1. Individuals who discontinue or withdraw from sports participation during the measurement period because of injury or other health-related problems
2. Individuals who sustain a new head injury during the measurement period
3. Individuals otherwise judged by the principal investigator to be unsuitable for participation in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kumazaki |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan
TEL
0252574315
kumazaki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kumazaki |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
950-3198
Address
Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan
TEL
0252574315
Homepage URL
kumazaki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Research Ethics Committee of Niigata University of Health and Welfare
Address
Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan
Tel
0252574455
rinri@nuhw.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
| 2026 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study in male collegiate soccer players. Participants will wear a mouthguard-based accelerometer during training sessions and matches to measure head impact acceleration exposure. Ocular motor function will also be assessed longitudinally after training and matches. In the analysis, participants will be classified post hoc into higher- and lower-exposure groups based on measured head impact exposure, and longitudinal changes in ocular motor function will be compared.
Management information
Registered date
| 2026 | Year | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070067
