UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of tongue lift movement in cerebrovascular disease patient
Title of the study (Brief title)	Evaluation of tongue lift movement in cerebrovascular disease patient
Region	Japan

Condition
Condition	cerebrovascular disease
Classification by specialty	Rehabilitation medicine Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the tongue lifting ability in cerebrovascular disease patient
Basic objectives2	Others
Basic objectives -Others	Physical capability in tongue lift movement
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Tongue movement dynamics to upward
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	cerebrovascular disease patient with motility disturbance of tongue
Key exclusion criteria	Disability to achieve necessary verbal communications
Target sample size	50

Research contact person
Name of lead principal investigator	Shogo Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-6687
Email	minagi@md.okayama-u.ac.jp

Public contact
Name of contact person	Shogo Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-6687
Homepage URL
Email	minagi@md.okayama-u.ac.jp

Sponsor
Institute	Department of Occlusal and Oral Functional Rehabilitation Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Institute
Department

Funding Source
Organization	Department of Occlusal and Oral Functional Rehabilitation Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Rehabilitation Medicine, Kawasaki Medical School Rehabilitation Center, Kawasaki Medical School
Name of secondary funｄer(s)	Oisaka Electric Equipment Ltd.

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	岡山大学病院、川崎医科大学附属病院 Okayama University Hospital, Kawasaki Medical School Hospital

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 30 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	The possibility that the disability of tongue lift movement might be related to dysarthria or dysphagia.

Management information
Registered date	2011 Year 09 Month 21 Day
Last modified on	2016 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007576