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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016594
Receipt No. 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

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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
Email 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
Email reiko_kamiji@sguc.ac.jp

Sponsor
Institute Sanyo Gakuen University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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