UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019728 |
|---|---|
| Receipt number | R000022785 |
| Scientific Title | Explain of distorted embodiment and sociality in Developmental Coordination Disorder |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2019/05/14 11:21:38 |
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Basic information
Public title
Explain of distorted embodiment and sociality in Developmental Coordination Disorder
Acronym
Embodiment and Sociality in Developmental Coordination Disorder
Scientific Title
Explain of distorted embodiment and sociality in Developmental Coordination Disorder
Scientific Title:Acronym
Embodiment and Sociality in Developmental Coordination Disorder
Region
| Japan |
Condition
Condition
Developmental coordination disorder
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between motor function and embodiment with sociality in Developmental coordination disorder.
Basic objectives2
Others
Basic objectives -Others
In this study, investigate the relationship between DCD severity and motor function, embodiment, sociality.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
DCD severity assessment(Movement Assessment Battery for Children - Second Edition), Motor function assessment(Motion 3D Force Plate), Embodiment assessment(Visual feedback delay detection task), Imitation assessment(Imitation interference effect), ASD assessment(High-Functioning Autism Spectrum Screening Questionnaire)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Standard development children and developmental coordination disorder's children in 6-15 years old.
Key exclusion criteria
Children has the motor disfunction by cerebral palsy and other injuries.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Nobusako |
Organization
Kio University
Division name
Neuro Rehabilitation Research Center
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakaturagi-gun, Nara, Japan
TEL
0745-54-1601
s.nobusako@kio.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nobusako |
Organization
Kio University
Division name
Neuro Rehabilitation Research Center
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakaturagi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
s.nobusako@kio.ac.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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University Ethics Committee
Address
4-2-2, Umaminaka, Koryo-cho, Kitakaturagi-gun, Nara, Japan
Tel
0745-54-1601
s.nobusako@kio.ac.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
| 2015 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fneur.2018.00114/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fneur.2018.00114/full
Number of participants that the trial has enrolled
71
Results
Children with clumsy manual dexterity have deficits in visuo-motor temporal integration and automatic-imitation function. There was a significant correlation between manual dexterity, and measures of visuo-motor temporal integration, and ASD traits and ADHD traits. Multiple regression analysis revealed that the DDT, which indicated visuo-motor temporal integration, was the greatest predictor of poor manual dexterity.
Results date posted
| 2019 | Year | 05 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 71 children, with an average age of 9.8 years participated in the current study.
The pDCD group (n = 29).
The TD group (n = 42).
Participant flow
All participants carried out the tasks in in each school's prescribed rooms.
Adverse events
There were no adverse events.
Outcome measures
Manual dexterity test, Delayed visual feedback detection task, Motor interference task, DSRS-C, SCQ, ADHD-RS, DCDQ.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment plans from public elementary and junior high schools and support schools. Performs a description of the document, only child of consent was obtained parents participate.
Management information
Registered date
| 2015 | Year | 11 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022785
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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