UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037888 |
|---|---|
| Receipt number | R000043194 |
| Scientific Title | Development of program to improve motor function of children with Developmental Coordination Disorder |
| Date of disclosure of the study information | 2019/09/14 |
| Last modified on | 2020/03/03 09:36:43 |
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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
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
hatanakar@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043194
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
