UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022214 |
|---|---|
| Receipt number | R000025588 |
| Scientific Title | The study to develop the management method of oral function in stroke patients |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/06/13 20:47:10 |
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Basic information
Public title
The study to develop the management method of oral function in stroke patients
Acronym
The study to develop the management method of oral function in stroke patients
Scientific Title
The study to develop the management method of oral function in stroke patients
Scientific Title:Acronym
The study to develop the management method of oral function in stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Medicine in general | Neurology | Vascular surgery |
| Neurosurgery | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the guideline of medical and dental care which maintains or improves the oral function of stroke patients in acute phase.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
morbidity, pneumonia rate, the rate which restart oral intake
time of assessment: at the discharge and after six months of transferred
Key secondary outcomes
status of oral hygiene, muscle mass of suprahyoid muscles, oral function, swallowing function
time of assessment: at the discharge and after six months of transferred
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We start oral care and dysphagia rehabilitation by the request from medical doctor. The frequency and term are different from the patient, but the continuing intervention about twice or thrice a week is conducted during hospitalization.
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
The admitted stroke patients in Tokyo Medical and Dental University hospital Faculty of Medicine and requested to department of dysphagia rehabilitation in Faculty of Dentistry.
Key exclusion criteria
nothing
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketoshi Maehara |
Organization
Tokyo Medical and Dental University
Division name
Department of functional neurosurgery
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo, 113-8549, Japan
TEL
03-5803-5266
maehara.nsrg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruka Tohara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo, Tokyo, 113-8549, Japan
TEL
03-5803-5559
Homepage URL
haruka-t@rd5.so-net.ne.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 01 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2016 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025588
