UMIN-CTR Clinical Trial

Basic information
Public title	Development of program to improve motor function of children with clumsy
Acronym	Development of program to improve motor function of children with clumsy
Scientific Title	Development of program to improve motor function of children with Developmental Coordination Disorder
Scientific Title:Acronym	Development of program to improve motor function of children with Developmental Coordination Disorder
Region	Japan

Condition
Condition	probable developmental coordination disorder
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Develop effective programs to improve motor skills for probable Developmental Coordination Disorder children living in the community
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Movement Assessment Battery for Children second edition
Key secondary outcomes	General self-efficacy scale for children revised

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Task-specific training
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	7 years-old <=
Age-upper limit	10 years-old >=
Gender	Male and Female
Key inclusion criteria	Children who experience difficulties in their lives due to clumsiness(eg, dropping objects, hitting objects), slowness or inaccuracy in the performance of motor skills(eg, scissors and blade operations, writing, riding bicycles, sporting)
Key exclusion criteria	Movement Assessment Battery for Children second edition value exceeds 15 percentile value
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Hatanaka
Organization	Osaka Kawasaki Rehabilitation University
Division name	Faculty of Rehabilitation
Zip code	597-0104
Address	158 Mizuma, Kaizuka City, Osaka Prefecture Japan
TEL	+81724466700
Email	hatanakar@kawasakigakuen.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Hatanaka
Organization	Osaka Kawasaki Rehabilitation University
Division name	Department of Rehabilitation
Zip code	597-0104
Address	158 Mizuma, Kaizuka City, Osaka Prefecture Japan
TEL	+81724466700
Homepage URL
Email	hatanakar@kawasakigakuen.ac.jp

Sponsor
Institute	Osaka Kawasaki Rehabilitation University
Institute
Department

Funding Source
Organization	Osaka Kawasaki Rehabilitation 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	Osaka Prefectural University Graduate School
Address	3-7-30 Habino, Habikino-shi, Osaka Japan
Tel	072-950-2111
Email	yumi@rehab.osakafu-u.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	大阪河﨑リハビリテーション大学

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 14 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	10
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	Completed
Date of protocol fixation	2019 Year 09 Month 07 Day
Date of IRB	2019 Year 03 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 14 Day
Last follow-up date	2019 Year 12 Month 14 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 09 Month 02 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043194