UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036750 |
|---|---|
| Receipt number | R000040708 |
| Scientific Title | The effect of sensory integration therapy on social interaction for children with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2023/06/26 12:22:04 |
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Basic information
Public title
The effect of sensory integration therapy on social interaction for children with Autism Spectrum Disorder
Acronym
The effect of SI on interaction for children with ASD
Scientific Title
The effect of sensory integration therapy on social interaction for children with Autism Spectrum Disorder
Scientific Title:Acronym
The effect of SI on interaction for children with ASD
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder children
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of sensory integration on social interaction for children with autism spectrum disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The evaluation social interaction(pre-post)
Key secondary outcomes
Canadian Occupational Performance Measure:COPM,heart rate variability of hight frequency:HRV-HF,interoceptive accuracy
(all outcomes measure pre-post)
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
sensory integration twice per week for 10wweeks
Interventions/Control_2
no-treatment for 10 weeks
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The person who was diagnosed in a doctor as autism spectrum disorder
2.IQ is greater than 70
Key exclusion criteria
1.The person who has medical diagnoses other than ASD
2.Blindness or Deafness
3.The person who has Limitation movement
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | ami |
| Middle name | |
| Last name | tabata |
Organization
Kyoto university
Division name
human health science rehabilitation of developmental disorders
Zip code
6068507
Address
shogoinkawara-machi-53 sakyo-ku kyoto
TEL
0757513819
tabata.ami.3e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | takehiro |
| Middle name | |
| Last name | sasai |
Organization
Kyoto university
Division name
human health science rehabilitation of developmental disorders
Zip code
6068507
Address
shogoinkawara-machi-53 sakyo-ku kyoto
TEL
0757513965
Homepage URL
sasai.takehiro.58c@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
human health science rehabilitation of developmental disorders
Institute
Department
Personal name
takehiro sasai
Funding Source
Organization
Kyoto university
human health science rehabilitation of developmental disorders
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 human health science rehabilitation of developmental disorders
Address
shogoinkawara-machi-53 sakyo-ku kyoto
Tel
0757513819
tabata.ami.3e@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
京都大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 05 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040708
