UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of assesment of turning over and falling down of a patient beside the bed.
Title of the study (Brief title)	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	Yudai Kawata
Organization	Tokyo medical and dental university
Division name	10F Neurosurgery
Address	Tokyo,shinjuku,takadanobaba,3-25-9sanmarina103
TEL	090-4052-5485
Email	y.kawata.mnrs@tmd.ac.jp

Public contact
Name of contact person	Yudai Kawata
Organization	Tokyo medical and dental university
Division name	10F Neurosurgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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