UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025814 |
|---|---|
| Receipt number | R000029687 |
| Scientific Title | Development of MMG/EMG Transducer for Evaluation of Skeletal Muscle Contraction |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/12/20 17:53:02 |
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Basic information
Public title
Development of MMG/EMG Transducer for Evaluation of Skeletal Muscle Contraction
Acronym
Development of MMG/EMG Transducer
Scientific Title
Development of MMG/EMG Transducer for Evaluation of Skeletal Muscle Contraction
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hisao Oka |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
Address
2-5-1, Kita-ku, Shikata-cho, Okayama-shi
TEL
086-235-6884
hoka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisao Oka |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
Address
2-5-1, Kita-ku, Shikata-cho, Okayama-shi
TEL
086-235-6884
Homepage URL
hoka@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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)
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
| 2017 | Year | 04 | 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
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.
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
