UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019728
Receipt No. 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 (Ver. 4)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Last 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
Email s.nobusako@kio.ac.jp

Public contact
1st 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
Email s.nobusako@kio.ac.jp

Sponsor
Institute Kio university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022785