UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto University Graduate School and Faculty of Medicine,Kyoto University Hospital, EthicsCommitte
Address	Konoecho Yoshida, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034279