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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035999
Receipt No. R000040664
Scientific Title Preliminary study on improvement of interpersonal relationship of child autistic spectrum disorder by animal robot (new type AIBO) without intellectual impairment
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/25

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Basic information
Public title Preliminary study on improvement of interpersonal relationship of child autistic spectrum disorder by animal robot (new type AIBO) without intellectual impairment
Acronym Study on effect of interpersonal relationship of child ASD by animal robot
Scientific Title Preliminary study on improvement of interpersonal relationship of child autistic spectrum disorder by animal robot (new type AIBO) without intellectual impairment
Scientific Title:Acronym Study on effect of interpersonal relationship of child ASD by animal robot
Region
Japan

Condition
Condition Child autistic spectrum disorder without intellectual impairment
Classification by specialty
Psychiatry Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of interpersonal relationship
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in way of touch and play with regard to AIBO of child ASD without MR and normal contorol.
Key secondary outcomes Changes of autistic symptoms after AIBO exposure of ASD without MR

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 ASD withuout MR
Interventions/Control_2 control
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
12 years-old >=
Gender Male and Female
Key inclusion criteria ASD
1.Children aged 6 to 12 who applied for posters posted .
2.IQ70 points or more in WISC-IV
3.Child diagnosed as autistic spectrum disorder
4.Child whose document agreement is obtained from the substitute person and consent of participation in this research is obtained from the subject .
Control
1.Children aged 6 to 12 who applied for posters posted on pediatrics and psychiatry.
2.There is no abnormality in medical examination at the age of 1 year and 3 years old by interview.
3.Child whose document agreement is obtained from the substitute person and consent .
Key exclusion criteria Child judged inappropriate by physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuya ono
Organization St Marianna University of Mdeicine
Division name Neuropsychiatry
Zip code
Address 2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL 044-977-8111
Email kazuya.ono@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuya ono
Organization st.marianna university school of medicine
Division name Neuropsychiatry
Zip code
Address 2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL 044-977-8111
Homepage URL
Email kazuya.ono@marianna-u.ac.jp

Sponsor
Institute st.marianna university school of medicine

Institute
Department

Funding Source
Organization st.marianna university school of medicine
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
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 聖マリアンナ医科大学

Other administrative information
Date of disclosure of the study information
2019 Year 03 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
2019 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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
2019 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040664

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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