UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023194 |
|---|---|
| Receipt number | R000026738 |
| Scientific Title | Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2017/07/18 16:59:39 |
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Basic information
Public title
Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Acronym
Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Scientific Title
Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Scientific Title:Acronym
Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Region
| Japan |
Condition
Condition
Healthy adults A patient with diabetes and arteriosclerosis will consider from now on, too.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Portable non-invasive cerebral oxygen saturation monitoring, measurement of muscle blood flow is, and a variation of the biological tissue oxygen saturation and hemoglobin in real time non-invasively be continuously measured invasive where possible.
Inadequate accumulation of data, reliability is to detect infrared light irradiation on the human body, and measure changes in the relative concentration of hemoglobin in the blood and oxygen saturation to provide medical information.
We use belt electrode skeletal muscle electric stimulation, healthy adults to electrical stimulation in the rehabilitation field very generally used as sinks current only 1 side leg and confirmed differences in blood flow and lower limb-to-HAND ai TOS, to verify the improvement of blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow measurement before and behind the electric stimulus method of treatment is tried.
Validate to validate the reliability and validity of the correlation between the thermography
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 bloodstream change in the electric stimulus therapy context of 20 minutes is confirmed. Measuring, it itself is about total 30 minutes.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
The one on which a pacemaker loaded the plantation type electrical appliance in the body
Something by which the severe past is in a leg
Pregnant woman or person with a possibility of the pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takumi Nakashima |
Organization
National Center for Global Health and Medicine
Division name
Rehabilitation
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
takunakashima@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takumi Nakashima |
Organization
National Center for Global Health and Medicine
Division name
Rehabilitation
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
takunakashima@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Own supply
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 15 | Day |
Last modified on
| 2017 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026738
