UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study to develop the management method of oral function in stroke patients
Title of the study (Brief title)	The study to develop the management method of oral function in stroke patients
Region	Japan

Condition
Condition	stroke
Classification by specialty	Medicine in general Neurology Vascular surgery Neurosurgery Rehabilitation medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the guideline of medical and dental care which maintains or improves the oral function of stroke patients in acute phase.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	morbidity, pneumonia rate, the rate which restart oral intake time of assessment: at the discharge and after six months of transferred
Key secondary outcomes	status of oral hygiene, muscle mass of suprahyoid muscles, oral function, swallowing function time of assessment: at the discharge and after six months of transferred

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Maneuver
Interventions/Control_1	We start oral care and dysphagia rehabilitation by the request from medical doctor. The frequency and term are different from the patient, but the continuing intervention about twice or thrice a week is conducted during hospitalization.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The admitted stroke patients in Tokyo Medical and Dental University hospital Faculty of Medicine and requested to department of dysphagia rehabilitation in Faculty of Dentistry.
Key exclusion criteria	nothing
Target sample size	60

Research contact person
Name of lead principal investigator	Taketoshi Maehara
Organization	Tokyo Medical and Dental University
Division name	Department of functional neurosurgery
Address	1-5-45, Yushima, Bunkyo, Tokyo, 113-8549, Japan
TEL	03-5803-5266
Email	maehara.nsrg@tmd.ac.jp

Public contact
Name of contact person	Haruka Tohara
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation
Address	1-5-45, Yushima, Bunkyo, Tokyo, 113-8549, Japan
TEL	03-5803-5559
Homepage URL
Email	haruka-t@rd5.so-net.ne.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Agency for Medical Research and Development
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 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	2016 Year 05 Month 06 Day
Last modified on	2016 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025588