UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027131 |
|---|---|
| Receipt number | R000031075 |
| Scientific Title | The effects of occupational therapist consultation on after-school children's clubs |
| Date of disclosure of the study information | 2017/04/25 |
| Last modified on | 2018/04/12 18:45:05 |
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Basic information
Public title
The effects of occupational therapist consultation on after-school children's clubs
Acronym
The effects of occupational therapist consultation on after-school children's clubs
Scientific Title
The effects of occupational therapist consultation on after-school children's clubs
Scientific Title:Acronym
The effects of occupational therapist consultation on after-school children's clubs
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Developmental Coordination Disorder
Learning Disorder
Communication Disability
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The occupational therapist will give consultation to the instructor of the child club after school. As a result, we examine the bias of sensory aspect of children with late development, inappropriate behavior, quality of life of children, and change of instructor's goal.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Goal Attainment Scaling
Key secondary outcomes
sensory profile short version
Eyberg Child Behavior Inventory
Kid-KINDLR Japanese Version
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with developmental disabilities 6 to 12 years old who go to after-school children's clubs
Key exclusion criteria
Formally developed children aged 6 to 12 who go to after-school children's clubs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Morikawa |
Organization
Kawasaki Junior College of Rehabilitaiton
Division name
Department of Occupational Therapy
Zip code
Address
672, Matsushima, Kurashiki city, Okayama prefecture
TEL
086-462-1111
morikawa@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Morikawa |
Organization
Kawasaki Junior College of Rehabilitaiton
Division name
Department of Occupational Therapy
Zip code
Address
672, Matsushima, Kurashiki city, Okayama prefecture
TEL
086-462-1111
Homepage URL
morikawa@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Junior College of Rehabilitaiton
Institute
Department
Personal name
Funding Source
Organization
Association of the School childcare Okayama prefecture
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 | 04 | Month | 25 | 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 | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The recruitment of after-school children's clubs will be conducted through association of school childcare okayama prefecture.
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031075
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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