UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of muscle stress and protective mechanizm in motor vehicle collision
Title of the study (Brief title)	Muscle stress in vehicle collision
Region	Japan

Condition
Condition	Normal subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elicidate the behavior changes of muscle stress in vehicle collision simulated experiment
Basic objectives2	Others
Basic objectives -Others	To elicidate the degree and distribution of neck and extrmities muscle. It would conduct the safety in motor vehicle collision.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The behavior change of muscle stress in the neck and extremities in motor vehicle collision
Key secondary outcomes	Body height and weight

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	braking in a car.
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)with a licence 2)Written informed consent with approval from our institutions was obtained from subjects prior to this experiments.
Key exclusion criteria	1)Subjects who is pregnnt are excluded. 2)Subjects who have cervical myelopathy, concomitant radiculopathy,mental disorders, motor neuron disease or peripheral neuropathy are excluded. 3)Subjects who had met traffic accidents are excluded. 4)Subjects who principaal investigator writes off are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	Masahiro Funaba
Organization	Yamaguchi University
Division name	Orthopedic Surgery
Address	Minami-Kogushi 1-1-1, Ube, Yamaguchi
TEL	0836-22-2266
Email	mfunaba@yamaguchi-u.ac.jp

Public contact
Name of contact person	Masahiro Funaba
Organization	Yamaguchi University
Division name	Orthopedic Surgery
Address	Minami-Kogushi 1-1-1, Ube, Yamaguchi
TEL	0836-22-2266
Homepage URL
Email	mfunaba@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	Mazda Motor Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 30 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030589