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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030020
Receipt No. 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 2018/11/22

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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
Middle name
Last name Toshihiro Kato
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Brain Function and Rehabilitation
Zip code
Address 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3819
Email kato.toshihiro.5z@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name hirotsugu nakamura
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Brain Function and Rehabilitation
Zip code
Address 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 090-3922-2099
Homepage URL
Email nakamura.hirotsugu.76w@kyoto-u.jp

Sponsor
Institute kyoto university
Institute
Department

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
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 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
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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 17 Day
Last follow-up date
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
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034279

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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