UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015171
Receipt number 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 12:10:24

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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)


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



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 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

606-8507

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 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

606-8507

Address

53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3819

Homepage URL


Email

kato.toshihiro.5z@kyoto-u.ac.jp


Sponsor or person

Institute

Department of Brain Function and Rehabilitation, Human Health Sciences, Graduate School of Medicine, 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

University Graduate School and Faculty of Medicine,Ethics Committe

Address

Yoshidakonoe-cho, 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

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

2014 Year 09 Month 12 Day

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name