UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030839
Receipt number R000035207
Scientific Title Research for effect of sensory integration therapy on brain function in autism spectrum disorder as measured by near-infrared spectroscopy and event-related potentials.
Date of disclosure of the study information 2018/01/16
Last modified on 2018/01/16 18:12:59

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Basic information

Public title

Research for effect of sensory integration therapy on brain function in autism spectrum disorder as measured by near-infrared spectroscopy and event-related potentials.

Acronym

Effect of sensory integration therapy on brain function in autism spectrum disorder.

Scientific Title

Research for effect of sensory integration therapy on brain function in autism spectrum disorder as measured by near-infrared spectroscopy and event-related potentials.

Scientific Title:Acronym

Effect of sensory integration therapy on brain function in autism spectrum disorder.

Region

Japan


Condition

Condition

autism spectrum disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of sensory integration therapy on brain function in autism spectrum disorder as measured by near-infrared spectroscopy and event-related potentials.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

oxyhemoglobin changes as measured by near-infrared spectroscopy

Key secondary outcomes

P300, Mismatch negativity, O'Connor Deftness Test, Purdue Pegboard Test, Social Responsiveness Scale, Japanese Sensory Profile


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

sensory integration therapy

Interventions/Control_2

usual care

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

6 years-old <=

Age-upper limit

10 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Children diagnosed with autism spectrum disorder according to the DSM-5 criteria.
2) Children with full-scale IQ scores over 70.

Key exclusion criteria

1) Children who presented with other psychiatric disorder according to the DSM-5 criteria, a neurological disorder, a head injury, a serious medical condition, or a history of substance abuse/dependence.
2) Children who have received sensory integration therapy by the occupational therapist in the present or the past.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toyosaku Ota

Organization

Nara Medical University

Division name

Department of Psychiatry

Zip code


Address

840 Shijyo-cho Kashihara, Nara

TEL

0744-22-3051

Email

toyosaku@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toyosaku Ota

Organization

Nara Medical University

Division name

Department of Psychiatry

Zip code


Address

840 Shijyo-cho Kashihara, Nara

TEL

0744-22-3051

Homepage URL


Email

toyosaku@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018 Year 01 Month 16 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

Preinitiation

Date of protocol fixation

2018 Year 01 Month 16 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 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

2018 Year 01 Month 16 Day

Last modified on

2018 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name