UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016594 |
|---|---|
| Receipt number | R000019244 |
| Scientific Title | Oral myofunctional training trial for CLinical Evidence-Learning disabilities |
| Date of disclosure of the study information | 2015/02/21 |
| Last modified on | 2015/02/21 12:30:55 |
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Basic information
Public title
Oral myofunctional training trial for CLinical Evidence-Learning disabilities
Acronym
ORACLE-LD
Scientific Title
Oral myofunctional training trial for CLinical Evidence-Learning disabilities
Scientific Title:Acronym
ORACLE-LD
Region
| Japan |
Condition
Condition
Intellectual disabilities and Developmental disabilities
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of oral myofunctional training for Intellectual disabilities and Developmental disabilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SDQ
Key secondary outcomes
Background (gender, age, medical history, medication), Developmental test,grip test,adverse event
Base
Study type
Study design
Basic design
Factorial
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
Oral myofunctional training (3 min, 5 times per day) program for 6 month
Interventions/Control_2
Conductive indivisual education and Oral myofunctional training (3 min, 5 times per day) program for 6 month
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
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Intellectual disabilities and Developmental disabilities
Key exclusion criteria
1) Person who is mechanically ventilated
2) Person who has serious conditions in the oral cavity
3) In case the doctor finds any difficulty for participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Kamiji |
Organization
Sanyo Gakuen University
Division name
Department of Psychology and Human Life
Zip code
Address
1-14-1,hirai,naka-ku,Okayama
TEL
086-901-0677
reiko_kamiji@sguc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Kamiji |
Organization
Sanyo Gakuen University
Division name
Department of Psychology and Human Life
Zip code
Address
1-14-1,hirai,naka-ku,Okayama
TEL
086-901-0677
Homepage URL
reiko_kamiji@sguc.ac.jp
Sponsor or person
Institute
Sanyo Gakuen University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology(MEXT)
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
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
JDS岡山支部（岡山県）、コンパス発達支援センター（福岡県、大分県、香川県、岡山県）、社会福祉法人みのり会（長崎県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 31 | 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
| 2015 | Year | 02 | Month | 21 | Day |
Last modified on
| 2015 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019244
| 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 |
