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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029603
Receipt No. R000033823
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.
Date of disclosure of the study information 2017/10/20
Last modified on 2018/10/22

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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
Middle name
Last name Tatsuya Hoshi
Organization Medical corporation Sonodakai
Takenotsuka Noushinkei
Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
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
Middle name
Last name Tatsuya Hoshi
Organization Takenotsuka Noushinkei Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
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
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
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
Anticipated trial start date
2017 Year 10 Month 20 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 10 Month 18 Day
Last modified on
2018 Year 10 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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