UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019171 |
|---|---|
| Receipt number | 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 17:19:49 |
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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
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/
norkowa@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Neurology, Department of Brain and Neurosciences, Faculty of Medicine, Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022163
