UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of effects on cognitive function and swallowing activity following after continuous chewing training with chewing start food of process lead in cerebrovascular disease: an open-label, randomized controlled.
Acronym	Evaluation of effects on cognitive function and swallowing activity following after continuous chewing training with chewing start food of process lead in cerebrovascular disease.
Scientific Title	Evaluation of effects on cognitive function and swallowing activity following after continuous chewing training with chewing start food of process lead in cerebrovascular disease: an open-label, randomized controlled.
Scientific Title:Acronym	Evaluation of effects on cognitive function and swallowing activity following after continuous chewing training with chewing start food of process lead in cerebrovascular disease.
Region	Japan

Condition
Condition	Cerebral vascular disease
Classification by specialty	Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine to clarify whether improvement on cognitive function and swallowing ability can be seen by performing continuous chewing training for the patients of cerebrovascular disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Development of the revised version of Hasegawa's dementia scale. Mini Mental State Examination. Fujishima dysphagia grade. Dysphagia severity scale. Japanese version the mann assessment of swallowing ability. Jaw opening muscle strength. Intraoral moisture conten.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Other
Interventions/Control_1	Control group. Regular rehabilitation for 2 months.
Interventions/Control_2	Interventions group. Regular rehabilitation and swallowing chewing twice a day chewing start food process leads for 2 months.
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	Hospitalized patients within 2 months had dysphagia showing grade 3 or more in Fujishima grade. They are diagnosed to swallow chewing food of process leads on videofluoroscopic examination in advance. They had cognitive function more than 10 points on development of the revised version of Hasegawa's dementia scale and are able to understand and perform for the order of swallowing that.
Key exclusion criteria	Person with consciousness disorder, Difficult to instruct chewing and swallowing. an aphasia. Cerebellar lesion,brain stem lesions including cerebral vascular disease. Eichner's classification A other than A.(Excluding those who have dentures.)
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Hoshi
Organization	Medical corporation Sonodakai Takenotsuka Noushinkei Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	1210064
Address	4-15-16, Hokima, Adachi-ku, Tokyo, 121-0064, Japan
TEL	03-5851-1108
Email	t_hoshi@reha.sonodakai.or.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Hoshi
Organization	Takenotsuka Noushinkei Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	1210064
Address	4-15-16, Hokima, Adachi-ku, Tokyo, 121-0064, Japan
TEL	03-5851-1108
Homepage URL
Email	t_hoshi@reha.sonodakai.or.jp

Sponsor
Institute	Medical corporation Sonodakai Takenotsuka Noushinkei Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Medical corporation Sonodakai Takenotsuka Noushinkei Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical corporation Sonodakai Takenotsuka Noushinkei Rehabilitation Hospital
Address	4-15-16, Hokima, Adachi-ku, Tokyo, 121-0064, Japan
Tel	03-5851-1108
Email	t_hoshi@reha.sonodakai.or.jp

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	2017 Year 10 Month 20 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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 25 Day
Date of IRB	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date	2023 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 18 Day
Last modified on	2022 Year 10 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033823