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

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 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


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

Value
https://center6.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