UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029603 |
|---|---|
| Receipt number | 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 | 2022/10/26 20:32:22 |
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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 | 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
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
t_hoshi@reha.sonodakai.or.jp
Sponsor or person
Institute
Medical corporation Sonodakai
Takenotsuka Noushinkei
Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033823
