UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029753 |
|---|---|
| Receipt number | R000033864 |
| Scientific Title | The effect of the oral function management for stroke patients. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2019/05/07 09:14:08 |
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Basic information
Public title
The effect of the oral function management for stroke patients.
Acronym
The effect of the oral function management for stroke patients.
Scientific Title
The effect of the oral function management for stroke patients.
Scientific Title:Acronym
The effect of the oral function management for 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 verify the effect of TMDU-type oral function management protocol on patients with acute stroke in multicenter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate of pneumonia
Key secondary outcomes
Status of oral hygiene, oral function, swallowing function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We intervene TMDU-type oral functional management protocol after the request from the attending doctor, and perform the protocol at least once a week at the hospitals with dentistry.
Interventions/Control_2
We perform normal oral functional management of each facility at the hospitals without dentistry.
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
Patients who are hospitalized in the acute phase of stroke and have dental treatment.
Key exclusion criteria
nothing
Target sample size
904
Research contact person
Name of lead principal investigator
| 1st name | Taketoshi |
| Middle name | |
| Last name | Maehara |
Organization
Tokyo Medical and Dental University
Division name
Functional neurosurgery
Zip code
113-8549
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 | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and oral rehabilitation
Zip code
113-8549
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo, 113-8549, Japan
Tel
03-3813-6111
d-hyoka.adm@tmd.ac.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 | 12 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 30 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033864
