UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036593 |
|---|---|
| Receipt number | R000041689 |
| Scientific Title | Examination of the relationship between the coordinated movement of children and the preschool (post) school life adjustment |
| Date of disclosure of the study information | 2019/04/25 |
| Last modified on | 2019/04/24 21:17:00 |
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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
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
kataokashin0919@yahoo.co.jp
Public contact
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
kataokashin0919@yahoo.co.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041689
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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