UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037263 |
|---|---|
| Receipt number | R000042485 |
| Scientific Title | The effects of sensory integration therapy for children with Developmental Coordination Disorder |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2020/06/15 12:16:02 |
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Basic information
Public title
The effects of sensory integration therapy for children with Developmental Coordination Disorder
Acronym
The effects of sensory integration therapy for children with Developmental Coordination Disorder
Scientific Title
The effects of sensory integration therapy for children with Developmental Coordination Disorder
Scientific Title:Acronym
The effects of sensory integration therapy for children with Developmental Coordination Disorder
Region
| Japan |
Condition
Condition
Developmental Coordination Disorder
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the sensory integration therapy for children with Developmental Coordination Disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement Assessment Battery for Children -Second Edition(M-ABC2)
Key secondary outcomes
1)Southern California Sensory Integration Test
2)Canadian Occupational Performance Measure(COPM)
3)The Japanese version of Developmental Coordination Disorder Questionnaire
5)Short Sensory Profile
6)ADHD-RS-4
7)Social Responsiveness Scale Second Edition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will receive sessions of sensory integration therapy (Ayres Sensory Integration Therapy)
Intervention period: 10 weeks
Intervention amount: 60 minutes per one time
Number of interventions: 20 times
Intervention frequency: once per 2 weeks
Interventions/Control_2
1)Not receive Sensory Integration therapy
2)Only usual care service
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
| 4 | years-old | <= |
Age-upper limit
| 8 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Have a diagnosis of DCD
2)full scale IQ higher than 70
3)SCSIT subtests score of <-0.7 SD on 3 or more
4)has attained percentile rank 15 on MABC2 total test score or any components
5)using the child development support project, after-school day service
Key exclusion criteria
1)Cerebral palsy
2)Neuro muscle disorder
3)Participants had experience of a sensory integration therapy in the past
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Sato |
Organization
Prefectural University of Hiroshima
Division name
Department of Occupational Therapy, Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara City, Hiroshima,Japan
TEL
0848-60-1245
yokodomot@gmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Sato |
Organization
Prefectural University of Hiroshima
Division name
Department of Occupational Therapy, Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara City, Hiroshima,Japan
TEL
0848-60-1245
Homepage URL
yokodomot@gmail.com
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara City, Hiroshima,Japan
Tel
0848-60-1120
yokodomot@gmail.com
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
| 2019 | Year | 07 | Month | 03 | 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
17
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 | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042485
