UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032414 |
|---|---|
| Receipt number | R000036966 |
| Scientific Title | Searching study about necessity of the training for ingestion in after-school care service. |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/04/27 18:53:11 |
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Basic information
Public title
Searching study about necessity of the training for ingestion in after-school care service.
Acronym
Searching study about necessity of the training for ingestion in after-school care service.
Scientific Title
Searching study about necessity of the training for ingestion in after-school care service.
Scientific Title:Acronym
Searching study about necessity of the training for ingestion in after-school care service.
Region
| Japan |
Condition
Condition
disability
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The significance which does training for ingestion in after-school care service is considered. A child or person with disabilities often have an obstacle in the eating swallow function, and risk of aspiration and suffocation. They may be able to suggest development of the eating swallow function of the child or person with disabilities also evade danger such as aspiraion and suffocation by training for ingestion in after-school care service, it's guessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The eating swallow function before and after intervention (movement of a swallow related quarter)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Swallowing evaluation and advice about eating (about the form of the posture, how to make them eat and the meal and danger of aspiration and suffocation) are performed. An after school care service staff does an eating training for 5 month.
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
| 6 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The child or person with disabilities using after school care service.
Key exclusion criteria
The person who can't take orally
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayako Tajiri |
Organization
Okayama University hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, JAPAN
TEL
086-235-6823
de18036@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Tajiri |
Organization
Okayama University hospital
Division name
Center for the special needs dentistry
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, JAPAN
TEL
086-235-6823
Homepage URL
de18036@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University hospital,Center for the special needs dentistry
Institute
Department
Personal name
Funding Source
Organization
Okayama University hospital,Center for the special needs dentistry
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
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
| 2018 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | 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
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036966
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| Registered date | File name |
| Research case data | |
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