UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055907 |
|---|---|
| Receipt number | R000063879 |
| Scientific Title | Masticatory function and trunk performance analysis predicts sports injury occurrence in athletes. |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2025/04/23 13:44:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Masticatory function and trunk performance analysis predicts sports injury occurrence in athletes.
Acronym
Masticatory function and trunk performance analysis predicts sports injury occurrence in athletes.
Scientific Title
Masticatory function and trunk performance analysis predicts sports injury occurrence in athletes.
Scientific Title:Acronym
Masticatory function and trunk performance analysis predicts sports injury occurrence in athletes.
Region
| Japan |
Condition
Condition
sports injury
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The research will analyze and compare the masticatory function of healthy subjects, athletes without sports injuries, and athletes with sports injuries from multiple perspectives, examine the relationship with trunk performance (postural maintenance and balance ability), and clarify how masticatory function is related to the presence of sports injuries. This research can establish a new screening method to predict the onset of sports injuries from masticatory function evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle stiffness
Key secondary outcomes
Muscle activity, occlusal contact status
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Stiffness of masseter muscle, muscle activity and left-right occlusal contact state during masticatory movements, spinal column angle, and balance ability
Interventions/Control_2
control
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
| 23 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes in the sports injury group are defined as those who have either
A history of surgery,
Residual pain at the injury site after 3 months, or have not yet been able to return to competition due to pain. However, athletes who cannot stand on one leg due to the injury are excluded. Athletes who do not fall into any of the above three categories shall be considered no complaint (healthy athletes).
Key exclusion criteria
Athletes unable to stand on one leg due to sports injuries
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KIMURA |
| Middle name | |
| Last name | KEISAKU |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture and Moxibustion
Zip code
950-3198
Address
1398 block(number) simami-cho, kita ward, Niigata-city, Niigata prefecture
TEL
+81-025-257-4455
keisaku-kimura@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | KIMURA |
| Middle name | |
| Last name | KEISAKU |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture and Moxibustion
Zip code
950-3198
Address
1398 block(number) simami-cho, kita ward, Niigata-city, Niigata prefecture
TEL
+81-025-257-4455
Homepage URL
keisaku-kimura@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 block(number) simami-cho, kita ward, Niigata-city, Niigata prefecture
Tel
+81-025-257-4455
keisaku-kimura@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
| 2024 | Year | 10 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063879
