UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035999
Receipt number 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 2021/05/20 10:13:37

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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 .
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 .
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 or person

Institute

st.marianna university school of medicine

Institute

Department

Personal name



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

Open public recruiting

Date of protocol fixation

2019 Year 01 Month 21 Day

Date of IRB

2019 Year 01 Month 21 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 25 Day

Last modified on

2021 Year 05 Month 20 Day



Link to view the page

Value
https://center6.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