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

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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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name