UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009356 |
|---|---|
| Receipt number | R000010990 |
| Scientific Title | Observation study on the relationship between the feeding/swallowing function and the degree of severity of disabled condition. |
| Date of disclosure of the study information | 2012/11/18 |
| Last modified on | 2012/11/18 21:36:32 |
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Basic information
Public title
Observation study on the relationship between the feeding/swallowing function and the degree of severity of disabled condition.
Acronym
The relationship between the feeding/swallowing function and the degree of severity of disabled condition.
Scientific Title
Observation study on the relationship between the feeding/swallowing function and the degree of severity of disabled condition.
Scientific Title:Acronym
The relationship between the feeding/swallowing function and the degree of severity of disabled condition.
Region
| Japan |
Condition
Condition
cerebral palsy ,intellectual disability
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I will examine the relationship of feeding and swallowing function and
the severity of disability using Yokochi's classification of the disability .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Method of nutritional ingestion
Feeding and swallowing function
Existence of lip closing function.
Existence of trusting the tongue habit
Manupulating abilities of food mass in oral cavity
Movement of abnormal pattern.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Handicapped persons, profound intelligence and motor disability, who are corresponded to a level of A1 to B3 of the Yokochi's classification
Key exclusion criteria
A person who are under the respiratory control by the tracheotomy
and eventually unable to ingest the food via the mouth.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomichi MURATA, DDS, PhD |
Organization
Okayama University Hospital
Division name
The Center of Special Needs Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku. Okayama City, Okayama Pref
TEL
086-235-6823
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko KANDA |
Organization
Okayama University
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku. Okayama City, Okayama Pref
TEL
086-235-6823
Homepage URL
px0m8qew@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
旭川荘医療・療育センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
cross-sectional study
Management information
Registered date
| 2012 | Year | 11 | Month | 18 | Day |
Last modified on
| 2012 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010990
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
