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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030401
Receipt No. R000034471
Scientific Title A study of assesment of turning over and falling down of a patient beside the bed.
Date of disclosure of the study information 2018/03/31
Last modified on 2017/12/14

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Basic information
Public title A study of assesment of turning over and falling down of a patient beside the bed.
Acronym A study of assesment of turning over and falling down of a patient beside the bed.
Scientific Title A study of assesment of turning over and falling down of a patient beside the bed.
Scientific Title:Acronym A study of assesment of turning over and falling down of a patient beside the bed.
Region
Japan

Condition
Condition Not limiting.
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating assesment of turning over and falling down of a patient and to reduce using swaddling band.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare number of turning over and falling down of a patient from this study period to before that.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 During hospitalization,we evaluate turning over and falling down of a patient when necessary.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have higher brain dysfunction and gait disturbance.
Doctor permits patient to partake.
Key exclusion criteria Patients who can't understand purpose of this study by higher brain dysfunction.
Patints who have behavior restriction by respiratory and circulatory disease.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yudai Kawata
Organization Tokyo medical and dental university
Division name 10F Neurosurgery
Zip code
Address Tokyo,shinjuku,takadanobaba,3-25-9sanmarina103
TEL 090-4052-5485
Email y.kawata.mnrs@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yudai Kawata
Organization Tokyo medical and dental university
Division name 10F Neurosurgery
Zip code
Address Tokyo,bunkyo,yushima,1-5-45
TEL 03-5803-5697
Homepage URL
Email y.kawata.mnrs@tmd.ac.jp

Sponsor
Institute Tokyo medical and dental university
Institute
Department

Funding Source
Organization Tokyo medical and dental university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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
2017 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 14 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034471

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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