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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019171
Receipt No. R000022163
Scientific Title An exploratory research on "fraility" exacerbation factors after the onset of cerebral infarction
Date of disclosure of the study information 2015/11/01
Last modified on 2015/09/30

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Basic information
Public title An exploratory research on "fraility" exacerbation factors after the onset of cerebral infarction
Acronym An exploratory research on "fraility" exacerbation factors after cerebral infarction
Scientific Title An exploratory research on "fraility" exacerbation factors after the onset of cerebral infarction
Scientific Title:Acronym An exploratory research on "fraility" exacerbation factors after cerebral infarction
Region
Japan

Condition
Condition cerebral infarction and transient ischemic attack
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to examine the factors of the ADL decline which arises to some patients, and to clarify relation with "fraility" after the onset of cerebral infarction or transient ischemic attack.
Basic objectives2 Others
Basic objectives -Others This is an exploratory research which examines the factor of the ADL decline which arises to some patients, and clarifies relation with "fraility" after the onset of cerebral infarction or transient ischemic attack.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes modified Rankin Scale one year after the onset
Key secondary outcomes Height, weight, vital signs, a dietary intake situation, the existence of risk factors and related laboratory data, and motor-function evaluation by a motion recorder one year after the onset

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 Motor-function evaluation by a motion recorder
(1) less than 14 days after development of symptoms
(2) for eight days before a leaving hospital day
(3) from last one month one year after the onset to back one month
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 1) A patient aged 20 and over who is hospitalized by acute cerebral infarction or transient ischemic attack defined with the NINDS CVD-III
2) A patient who can agree with this research himself
3) A patient who can take part in the motor-function evaluation by the motion recorder
4) The existence of a recurrence does not ask about cerebral infarction or transient ischemic attack.
Key exclusion criteria 1) A patient whom the motor-function evaluation by a motion recorder judged to be difficult for critical complications such as heart failure, a respiratory failure, hepatic insufficiency, renal insufficiency, multiple organ failure
2) A woman under pregnancy or with the possibility of pregnancy
3) In addition, a patient whom the research responsibility doctor judged to be unsuitable as an object
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Nakashima
Organization Department of Brain and Neurosciences, Faculty of Medicine, Tottori University
Division name Division of Neurology
Zip code
Address 36-1 Nishi-machi, Yonago 683-8504, Japan
TEL 81-859-386757
Email kenaka@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisanori Kowa
Organization Department of Brain and Neurosciences, Faculty of Medicine, Tottori University
Division name Division of Neurology
Zip code
Address 36-1 Nishi-machi, Yonago 683-8504, Japan
TEL 81-859-386757
Homepage URL http://neurol.med.tottori-u.ac.jp/
Email norkowa@med.tottori-u.ac.jp

Sponsor
Institute Division of Neurology, Department of Brain and Neurosciences, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 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
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 Preinitiation
Date of protocol fixation
2015 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 30 Day
Last modified on
2015 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022163

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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