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 | 2025/07/29 13:38:51 |
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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 | Toyosaku |
| Middle name | |
| Last name | Ota |
Organization
Nara Medical University
Division name
Department of Psychiatry
Zip code
634-8522
Address
840 Shijyo-cho Kashihara, Nara
TEL
0744-22-3051
toyosaku@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyosaku |
| Middle name | |
| Last name | Ota |
Organization
Nara Medical University
Division name
Department of Psychiatry
Zip code
634-8522
Address
840 Shijyo-cho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
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
Nara Medical University Ethics Committee
Address
840 Shijyo-cho Kashihara, Nara
Tel
0744-22-3051
icats@naramed-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
| 2018 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
We evaluated nine children with ASD as measured by event-related potentials (P300 and mismatch negativity) and near-infrared spectroscopy before intervention and after the sensory integration intervention for 3 months. As a result, amplitudes of mismatch negativity were significantly greater than those at baseline. There were no significant differences in P300 and near-infrared spectroscopy.
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
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
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 29 | Day |
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
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035207
