UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060585 |
|---|---|
| Receipt number | R000069301 |
| Scientific Title | A Multifaceted Investigation of Concussion Risk in Japanese American Football Players: Associations with Helmet Structure and Neck Muscle Strength |
| Date of disclosure of the study information | 2026/02/08 |
| Last modified on | 2026/02/05 10:34:41 |
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Basic information
Public title
An Investigation of Risk Factors for Concussion in Japanese American Football: Associations with Helmet Structure and Neck Muscle Strength
Acronym
Multifactor Concussion Risk Study : Helmet Structure & Neck Strength
Scientific Title
A Multifaceted Investigation of Concussion Risk in Japanese American Football Players: Associations with Helmet Structure and Neck Muscle Strength
Scientific Title:Acronym
Multifactor Concussion Risk Study : Helmet Structure & Neck Strength
Region
| Japan |
Condition
Condition
Concussion
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish foundational knowledge for developing practical preventive measures to reduce the risk of head injuries and concussions among university American football players in Japan. Specifically, it will conduct the following investigations and analyses from two perspectives: protective gear (helmets) and physical factors (the neck region).
1. Through interviews, we will determine the actual usage patterns of helmets employed in Japanese university football. We will disassemble helmets to compare and examine their structural characteristics, clarifying their impact on preventing head injuries.
2. We will measure the circumference, muscle strength, and stiffness of players' necks. We will analyze the relationship between these measurements and helmet type, and further clarify the association with the risk of concussion occurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Helmet Type: manufacturer, model name, fit
2. Neck Measurement: measurement of neck circumference.
3. Neck Muscle Strength and Muscle Hardness Measurement: measurement of maximum neck muscle strength (flexion, extension, lateral flexion) using a dedicated dynamometer (Mutus F1), and measurement of muscle hardness using an ultrasound device (Canon Apria).
Key secondary outcomes
Age, height, weight, athletic history, medical history (including head injuries and concussions - mandatory items), position, helmet fit sensation, SCAT6 results (Sport Concussion Assessment Tool 6).
For concussion patients: SCAT6 retest, date and time of injury, and detailed circumstances of injury.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. University students (years 1 to 4) who belong to the Senshu University American football team and have provided written informed consent.
2. Healthy participants who can undergo neck circumference measurement, neck muscle strength testing, and neck muscle hardness assessment without injury and with normal performance of all measurements.
Key exclusion criteria
1. Participants will be excluded if written informed consent cannot be obtained.
2. Participants who become unable to continue measurements due to progression of any disease or medical condition.
3. Participants for whom the participating physicians determine that measurements should be discontinued.
4. Any other participants deemed inappropriate for the study by the participating physicians.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | SHU |
| Middle name | |
| Last name | SOMEMURA |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, JAPAN
TEL
0449778111
s3somemura@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | SHU |
| Middle name | |
| Last name | SOMEMURA |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, JAPAN
TEL
0449778111
Homepage URL
s3somemura@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511, JAPAN
Tel
0449778111
s3somemura@marianna-u.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 | 02 | Month | 08 | 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 | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eligible participants will be university students (years 1 to 4) who belong to the Senshu University American football team and provide informed consent.
During the study period, information will be collected once per year using a questionnaire administered at the start of each academic year (around May to June, after new students join the team).
Neck circumference, neck muscle strength, and SCAT6 (Sport Concussion Assessment Tool 6) will be measured at the Department of Sports Medicine, St. Marianna University School of Medicine, or at Senshu University.
Muscle hardness will be measured using an ultrasound device in the orthopaedic outpatient clinic at St. Marianna University School of Medicine.
To evaluate longitudinal changes over time, measurements will be performed annually.
Management information
Registered date
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069301
