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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027184
Receipt No. 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

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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
Email 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
Email child_77_33@yahoo.co.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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