UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048993 |
|---|---|
| Receipt number | R000055808 |
| Scientific Title | Motor-linked implicit and explicit learning through step by step tasks in children with Autism Spectrum Disorders |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2022/09/21 18:25:17 |
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Basic information
Public title
Motor-linked implicit and explicit learning through step by step tasks in children with Autism Spectrum Disorders
Acronym
Motor-linked implicit and explicit learning through step by step tasks in children with Autism Spectrum Disorders
Scientific Title
Motor-linked implicit and explicit learning through step by step tasks in children with Autism Spectrum Disorders
Scientific Title:Acronym
Motor-linked implicit and explicit learning through step by step tasks in children with Autism Spectrum Disorders
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 investigate the effect of step-by-step tasks on children with autism spectrum disorder
To reveal the characteristics of motor development in children with autism spectrum disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the degree of attainment on step-by-step tasks and the tendency of autism spectram disorder
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects take a step-by-step task using two small balls. On one condition, they do all the movements at one time with the sequence of movements. And on the other condition, they do each small movement step by step. The level of achievement in both conditions will be compared.
Interventions/Control_2
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
| 7 | years-old | <= |
Age-upper limit
| 13 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children with the diagnosis of autism spectrum disorder based on DSM-5 or ICD-11
Children aged 7 to 12
Children who can verbally communicate
Children who took an intelligence test, and who are able to share the results for this study
Children whose parents (or a care giver) sign the consent form of this study
Key exclusion criteria
Children who are hospitalized or live in a care center
Children who have a developmental disability other than autism spectrum disorder
Children who have a physical disability
Children who have Intelligence Quotientlower than 70, and have difficulty understanding language
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MISAKO |
| Middle name | |
| Last name | SANO |
Organization
Graduate School of Medicine, Nagoya University
Division name
Occupational Therapy Sciences, Prevention & Rehabilitation Sciences Course , Division of Integrated Care Sciences Technology, Department of Integrated Health Sciences
Zip code
461-8673
Address
1-1-20, Daiko-Minami, Higashi-ku, Nagoya, Aichi
TEL
052-719-3177
misako.sano@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | MISAKO |
| Middle name | |
| Last name | SANO |
Organization
Graduate School of Medicine, Nagoya University
Division name
Occupational Therapy Sciences, Prevention & Rehabilitation Sciences Course
Zip code
461-8673
Address
1-1-20, Daiko-Minami, Higashi-ku, Nagoya, Aichi
TEL
052-719-3177
Homepage URL
misako.sano@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Nagoya University Certified Review Board
Address
65-banchi, Tsurumai-cho, Showa-ku, Aichi.
Tel
0527442423
ethics@med.nagoya-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
| 2022 | Year | 12 | Month | 31 | 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
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects take a step-by-step task using two small balls. On one condition, they do all the movements at one time with the sequence of movements. And on the other condition, they do each small movement step by step. The level of achievement in both conditions will be compared.
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
