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

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 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

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

Value
https://center6.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