UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058187 |
|---|---|
| Receipt number | R000057829 |
| Scientific Title | Motor skills training aimed at reducing psychosocial problems in probable developmental coordination disorder children and parents: a randomized controlled trial |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/16 12:00:51 |
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Basic information
Public title
Motor skills training aimed at reducing psychosocial problems in clumsy children and parents: a randomized controlled trial
Acronym
Motor skills training aimed at reducing psychosocial problems in clumsy children and parents
Scientific Title
Motor skills training aimed at reducing psychosocial problems in probable developmental coordination disorder children and parents: a randomized controlled trial
Scientific Title:Acronym
Motor skills training aimed at reducing psychosocial problems in probable developmental coordination disorder children and parents: a randomized controlled trial
Region
| Japan |
Condition
Condition
children with probable developmental coordination disability
Classification by specialty
| Pediatrics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether providing motor skill training and parent training to children and parent probable developmental coordination improves anxiety and depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CBCL(Child Bhavior Chechlist)/6-18 Before and after exercise intervention: once a week, 1 hour and 30 minutes for 8 weeks
Key secondary outcomes
Parenting Stress Index Before and after exercise intervention: once a week, 1 hour and 30 minutes for 8 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
motor skill training
Interventions/Control_2
no intervention
Interventions/Control_3
no intervention
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
Typical development (Those who score MABC2 total score 16 percentile or more)
probably Developmental Coordination Disorder (Those who score less than MABC2 total score16 percentile)
Key exclusion criteria
cereblal palsy, progressive disease
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hatanaka |
Organization
Osaka Prefecture University Graduate School
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
599-8531
Address
3-7-30 Habikino, Habikino-City, Osaka, Japan
TEL
09085230098
hatanakar@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hatanaka |
Organization
Osaka Kawasaki Rehabilitation Univercity
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158, Mizuma, Kaizuka, Osaka
TEL
+81724466700
Homepage URL
hatanakar@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Prefecture University Graduate School
Institute
Department
Personal name
Ryota Hatanaka
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 Prefecture University Graduate School
Address
3-7-30 Habikino, Habikino-City, Osaka, Japan
Tel
+81729502111
gr-hab-shinsa@omu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-120
Org. issuing International ID_1
Osaka Prefecture University Graduate School
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 16 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057829
