UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023194
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takunakashima@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.