UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030401
Receipt number 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 21:23:06

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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 or person

Institute

Tokyo medical and dental university

Institute

Department

Personal name



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

Value
https://center6.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