UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000039386
Receipt No. R000044146
Scientific Title Effects of Fidgeting on Cognitive Function and its Therapeutic Application for Neurodevelopmental Disorder
Date of disclosure of the study information 2021/03/31
Last modified on 2021/08/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000044146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.