UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of MMG/EMG Transducer for Evaluation of Skeletal Muscle Contraction
Title of the study (Brief title)	Development of MMG/EMG Transducer
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validation of developed MMG/EMG Transducer for Evaluation of Skeletal Muscle Contraction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Validation of MMG and EMG Signal of developed Transducer
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The subject makes (1)Isometric Contarction, (2)Isotonic Contraction, (3)Pedaling Wheel Chair Exercise by using the developed transducer attached on the muscle surface (totally for an hour).
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	Not applicable
Gender	Male
Key inclusion criteria	1)Subject without any problem of the orthopedic desease 2) Subject whose age is elder than 20 years old when he agreed with the IC 3) Subject who submitted the document agreement after he received the enough explanation for participation to this study
Key exclusion criteria	1)Subject with the problem of the exercise function 2)Subject who occurs a rash to the conductive cream 3)Sbject who feels unpleasantly by wearing the transducer 4)Subject whom the investigators judged as an inappropriate subject
Target sample size	10

Research contact person
Name of lead principal investigator	Hisao Oka
Organization	Okayama University
Division name	Graduate School of Health Sciences
Address	2-5-1, Kita-ku, Shikata-cho, Okayama-shi
TEL	086-235-6884
Email	hoka@md.okayama-u.ac.jp

Public contact
Name of contact person	Hisao Oka
Organization	Okayama University
Division name	Graduate School of Health Sciences
Address	2-5-1, Kita-ku, Shikata-cho, Okayama-shi
TEL	086-235-6884
Homepage URL
Email	hoka@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2018 Year 11 Month 18 Day
Date of closure to data entry	2018 Year 11 Month 18 Day
Date trial data considered complete	2018 Year 11 Month 18 Day
Date analysis concluded	2018 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The results of MMG and EMG data, measured by the developed MMG / EMG hybrid transducer, reflected the muscle contraction strength during dynamic exercises. Then this transducer is effective in simultaneous measurement of MMG / EMG signals.
Other related information

Management information
Registered date	2017 Year 01 Month 23 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029687