UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030020 |
|---|---|
| Receipt number | R000034279 |
| Scientific Title | The effect of sensory integration therapy for children with autism spectrum disorder |
| Date of disclosure of the study information | 2017/11/17 |
| Last modified on | 2019/10/09 12:26:09 |
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Basic information
Public title
The effect of sensory integration therapy for children with autism spectrum disorder
Acronym
The effect of sensory integration therapy for children with autism spectrum disorder
Scientific Title
The effect of sensory integration therapy for children with autism spectrum disorder
Scientific Title:Acronym
The effect of sensory integration therapy for children with autism spectrum disorder
Region
| Japan |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the sensory integration treatment for children with autism spectrum disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are COPM(Canadian Occupational Performance Measure),GAS(Goal Attainment Scaling),VABS-2(Vineland Adaptive Behavior Scales, Second Edition),CBCL(Child Behavior Checklist)before the treatment of sensory integration therapy and at the end of the program
Key secondary outcomes
Japanese Sensory Profile
Japanese Sensory Processing Measure-Preschool
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
sensoy integration therapy
Interventions/Control_2
no interventions
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
| 2 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The children with the diagnosis with autistic spectrum symptom (including the autism disorder).
2)The children who are judged to be severeness as a result of judgment of the severity of ASD by Childhood Autism Rating Scale.
3)Children with developmental quotient 70 or less as a result of New Edition K-type Developmental test 2001 performed in child consultation centers.
Key exclusion criteria
1)The children whom clear physical disorders such as cerebral infantile palsy are found in.
2)The children with the limit that is medical in exercise tests such as epilepsy or heart disorder.
3)The children who have received sensory integration therapy by the occupational therapist in the present, the past.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kato |
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
Department of Brain Function and Rehabilitation
Zip code
6068507
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3819
kato.toshihiro.5z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | nakamura |
| Middle name | |
| Last name | hirotsugu |
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
Department of Brain Function and Rehabilitation
Zip code
6068507
Address
53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
090-3922-2099
Homepage URL
nakamura.hirotsugu.76w@kyoto-u.jp
Sponsor or person
Institute
kyoto university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine,Kyoto University Hospital, EthicsCommitte
Address
Konoecho Yoshida, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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 | 11 | Month | 17 | 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
9
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 | 11 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 25 | 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 | 11 | Month | 17 | Day |
Last modified on
| 2019 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
