UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027184 |
|---|---|
| Receipt number | R000031040 |
| Scientific Title | A pilot study on the effectiveness of the task-oriented approach to six years children with clumss. Study by randomized comparison test using School AMPS. |
| Date of disclosure of the study information | 2017/05/02 |
| Last modified on | 2019/08/02 17:06:19 |
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Basic information
Public title
A pilot study on the effectiveness of the task-oriented approach to six years children with clumss. Study by randomized comparison test using School AMPS.
Acronym
A pilot study on the effectiveness of the task-oriented approach to six years children with clumss. Study by randomized comparison test using School AMPS.
Scientific Title
A pilot study on the effectiveness of the task-oriented approach to six years children with clumss. Study by randomized comparison test using School AMPS.
Scientific Title:Acronym
A pilot study on the effectiveness of the task-oriented approach to six years children with clumss. Study by randomized comparison test using School AMPS.
Region
| Japan |
Condition
Condition
clumsy
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intervention on clumsiness by using basic theory of CO-OP for children with clumsiness of 6-year old . To compare the intervention effects with intervening group and control group.
The evaluation is school AMPS and DCDQ Japanese version, M - ABC 2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
School Assessment of Motor and Process Skills
Before intervention,
immediately after intervention, three months later
Key secondary outcomes
The Developmental Coordination Disorder Questionnaire
Four weeks before intervention, immediately after intervention, three months later
Movement Assessment Battery for Children second edition
Before intervention, immediately after intervention, three months later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention
Intervention using task-oriented theoryThe intervention period is 8 weeks
45 minutes per intervention once a week
Interventions/Control_2
Contorol
No intervention for 8 weeks, Normal nursery school life only
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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 5 to 6
DCDQ total score is 40 points or less
Children whose consent was obtained in writing by the substitute
Key exclusion criteria
Child with severe mental retardation, very weak communication with people
Child that the research staff acknowledged inappropriate to conduct this research
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masanori yasunaga |
Organization
Hiroshima University postgraduate doctoral course
Division name
Graduate School of Health Sciences
Zip code
Address
1-2-3 Kusami Minamiku,Hiroshima
TEL
082-257-5440
child_77_33@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masanori yasunaga |
Organization
Hiroshima Universityy postgraduate doctoral course
Division name
Graduate School of Health Sciences
Zip code
Address
1-2-3 Kusami Minamiku,Hiroshima
TEL
082-257-5440
Homepage URL
child_77_33@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima 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
Address
Tel
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
| 2017 | Year | 05 | Month | 02 | 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
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
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031040
