UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004669 |
|---|---|
| Receipt number | 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 10:33:19 |
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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
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
irihiro-ham@umin.ac.jp
Sponsor or person
Institute
Department of clinical pharmacology, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005501
