UMIN-CTR Clinical Trial

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
Email	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
Email	misako.sano@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055808