UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033636 |
|---|---|
| Receipt number | R000038210 |
| Scientific Title | Application of fiber reinforced thermoplastic resin to face guard |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/10/01 18:05:04 |
* 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
Application of fiber reinforced thermoplastic resin to face guard
Acronym
Application of fiber reinforced thermoplastic resin to face guard
Scientific Title
Application of fiber reinforced thermoplastic resin to face guard
Scientific Title:Acronym
Application of fiber reinforced thermoplastic resin to face guard
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
On the face guard (FG) using the fiber reinforced thermoplastic resin (FRTP) as the core material, there were some reports the basic physical property evaluation such as the impact test, which were that FRTP were superior to the conventional material.From the clinical point of view, in order to evaluate the effectiveness and influence of using FRTP as a core material, we conducted field tests under the wearing a prototype FG using FRTP as a core material.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Influence on exercise performance under the wearing a prototype FG at dash, short pass, long pass, dribble, heading, which are the basic movement of soccer
Key secondary outcomes
comfortability, affected area protection ability, displacement during play, and field of view
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform basic action of soccer with wearing fiber reinforced proto type faceguard
Each task 5 minutes, total 5 tasks 25 minutes
Interventions/Control_2
Perform basic action of soccer with wearing conventional type faceguard
Each task 5 minutes, total 5 tasks 25 minutes
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
soccer players
Key exclusion criteria
Persons who have diseases and injuries that interfere with the basic action of soccer
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | CHUREI Hiroshi |
Organization
Tokyo Medical and Dental University
Graduate School of Medical and Dental Sciences
Division name
Sports Medicine/Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5867
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | CHUREI Hiroshi |
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name
Sports Medicine/Dentistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5867
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 10 | Month | 01 | 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
| 2018 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038210
