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Recruitment status Completed
Unique ID issued by UMIN UMIN000015171
Receipt No. R000017641
Scientific Title The effect of sensory-motor therapy for children with autism spectrum disorder
Date of disclosure of the study information 2014/09/16
Last modified on 2019/10/09

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Basic information
Public title The effect of sensory-motor therapy for children with autism spectrum disorder
Acronym The effect of sensory-motor therapy for children with autism spectrum disorder
Scientific Title The effect of sensory-motor therapy for children with autism spectrum disorder
Scientific Title:Acronym The effect of sensory-motor 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-motor 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 JPAN(Japanese Playful Assessment for Neuropsychological Abilities),Sensory Profile before the treatment of sensory-motor program and at the end of the program
Key secondary outcomes The second outocome measure is Child Behavior Checklist(CBCL)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 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 sensory-motor treatment
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
4 years-old <=
Age-upper limit
8 years-old >=
Gender Male and Female
Key inclusion criteria 1)Diagnosed with autistic disorder or Asperger's disorder or pervasive developmental disorder not-otherwise-specified
2) Full IQ above 70 measured with Wechsler Intelligence Scale for Children-Fourth Edition or Wecheler Preschool and Primary Scale of Intelligence
3)Infancy score above 8 and Childhood score above 13 measured with Pervasive Developmental Disorders Autism Society Japan Rating Scale
Key exclusion criteria 1)Children with physical handicapped(cerebral palsy)
2)Taked rehabiritation service
3)Clinical judgment of ineligility for some reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
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
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 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
Homepage URL
Email kato.toshihiro.5z@kyoto-u.ac.jp

Sponsor
Institute Department of Brain Function and Rehabilitation, Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2014 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2014 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 04 Month 30 Day
Date analysis concluded
2017 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 16 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/ctr_e/ctr_view.cgi?recptno=R000017641


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