UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the relationship between the coordinated movement of children and the preschool (post) school life adjustment
Acronym	Examination of the relationship between the coordinated movement of children and the preschool (post) school life adjustment
Scientific Title	Examination of the relationship between the coordinated movement of children and the preschool (post) school life adjustment
Scientific Title:Acronym	Examination of the relationship between the coordinated movement of children and the preschool (post) school life adjustment
Region	Japan

Condition
Condition	DCD,ASD,ADHD,LD
Classification by specialty	Pediatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Collaborative movement reveals the influence on school life skills by examining the relationship between the coordinated movement of older children and the school adaptation before and after admission using the child development support project, after-school day service, nursery school and kindergarten The purpose is to.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	KIDS Test (type C) M-ABC2 DCDQ-J SCO SCD New version SM scale SP wISC-4 Tanaka bine inspection Behavioral observation of stuttering Articulation test ADIR PARS
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	Maneuver Other
Interventions/Control_1	M-ABC2
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	5 years-old <=
Age-upper limit	7 years-old >
Gender	Male and Female
Key inclusion criteria	Intellectual test has an IQ of 80 or more or a development test of 80 or more
Key exclusion criteria	Children with physical disabilities, children with neurological abnormalities, children with chromosomal abnormalities, orthopedic diseases, children with an IO and DO of 80 or less
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name shin Middle name Last name kataoka
Organization	Kio University
Division name	Graduate School of Health Sciences
Zip code	5998244
Address	ueno409, Naka Ward, Sakai City, Osaka Prefecture
TEL	09052492360
Email	kataokashin0919@yahoo.co.jp

Public contact
1st name of contact person	1st name shin Middle name Last name kataoka
Organization	Kio University
Division name	Graduate School of Health Sciences
Zip code	5998244
Address	ueno409, Naka Ward, Sakai City, Osaka Prefecture
TEL	09052492360
Homepage URL
Email	kataokashin0919@yahoo.co.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	0309

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kio University
Address	ueno409, Naka Ward, Sakai City, Osaka Prefecture
Tel	09052492360
Email	kataokashin0919@yahoo.co.jp

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	2019 Year 04 Month 25 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 05 Month 15 Day
Date of IRB
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 24 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041689