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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004669
Receipt No. R000005501
Scientific Title The investigation of the factors effect on cerebral hemodynamic responses to posture change of healthy and post cerebral infarction subjects using Near-Infrared Time-Resolved Spectroscopy
Date of disclosure of the study information 2010/12/06
Last modified on 2018/06/20

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Basic information
Public title The investigation of the factors effect on cerebral hemodynamic responses to posture change of healthy and post cerebral infarction subjects using Near-Infrared Time-Resolved Spectroscopy
Acronym The factors effect on cerebral hemodynamic responses to posture change using Near-Infrared Time-Resolved Spectroscopy
Scientific Title The investigation of the factors effect on cerebral hemodynamic responses to posture change of healthy and post cerebral infarction subjects using Near-Infrared Time-Resolved Spectroscopy
Scientific Title:Acronym The factors effect on cerebral hemodynamic responses to posture change using Near-Infrared Time-Resolved Spectroscopy
Region
Japan

Condition
Condition normal subjects
post cerebral infarction subjects
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the factors effect on cerebral hemodynamic responses to posture change and the influences of the cerebral infraction to cerebral hemodynamic responses.
Basic objectives2 Others
Basic objectives -Others observation study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cerebral blood flow responses to posture change
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 and Female
Key inclusion criteria normal and post cerebral infarction subjects who can stand themselves
Key exclusion criteria subjects who can not stand themselves
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Watanabe
Organization Hamamatsu University School of Medicine
Division name Department of clinical pharmacology
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Sizuoka, Japan
TEL 053-435-2385
Email irihiro-ham@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Irisawa
Organization Hamamatsu University School of Medicine
Division name Department of clinical pharmacology
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Sizuoka, Japan
TEL 053-435-2385
Homepage URL
Email irihiro-ham@umin.ac.jp

Sponsor
Institute Department of clinical pharmacology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Department of clinical pharmacology, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 浜松医科大学付属病院

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2014 Year 11 Month 01 Day

Other
Other related information The investigated factors are intima-media thickness of carotid artery, blood chemical analysis, medication, and the location of cerebral infarction.

Management information
Registered date
2010 Year 12 Month 06 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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