UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Fidgeting on Cognitive Function and its Therapeutic Application for Neurodevelopmental Disorder
Acronym	Fidgeting on Neurodevelopmental Disorder
Scientific Title	Effects of Fidgeting on Cognitive Function and its Therapeutic Application for Neurodevelopmental Disorder
Scientific Title:Acronym	Fidgeting on Neurodevelopmental Disorder
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of fidgeting on cognitive function in normal children and children with autism spectrum disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Performance on cognitive tasks and cortical activity before and after fidgeting
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	Behavior,custom
Interventions/Control_1	Fidgeting, once for 30~40 minutes
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	6 years-old <
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	Children at 6-18 years old diagnosed with autism spectrum disorder at clinics, either who have already been participating in the research project "Learning and Communication Support and Evaluation for Children with Neurodevelopmental Disorder (Approved #1212 by Kyoto University Graduate School and Faculty of Medicine, Ethics Committee)", or who respond to the advertisements for participation into the research. In addition, typically developing children at 6-18 years old, who do not have any diagnosis of psychiatric and neurodevelopmental disorder.
Key exclusion criteria	Children who show difficulty in understanding of research aims and contents, due to factors such as intellectual disability.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yukiori Middle name Last name Goto
Organization	Kyoto University
Division name	Primate Research Institute, Cognition and Learning Section
Zip code	484-8506
Address	41-2 Kanrin, Inuyama, Aichi
TEL	0568-63-0551
Email	goto.yukiori.5c@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Higuchi
Organization	Kyoto University
Division name	Primate Research Institute, General Affairs Office
Zip code	484-8506
Address	41-2 Kanrin, Inuyama, Aichi
TEL	0568-63-0512
Homepage URL
Email	soumu_reichou@mail2.adm.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University, Primate Research Institute, Cognition and Learning Section
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto University, KOKORO Research Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
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	京都大学こころの未来研究センター（京都府） 京都大学霊長類研究所（愛知県）

Other administrative information
Date of disclosure of the study information	2021 Year 03 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	Suspended
Date of protocol fixation	2020 Year 02 Month 03 Day
Date of IRB	2021 Year 02 Month 18 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 04 Day
Last modified on	2021 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044146