UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039386 |
|---|---|
| Receipt number | 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 09:10:30 |
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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
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
soumu_reichou@mail2.adm.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Primate Research Institute, Cognition and Learning Section
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044146
| 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 |
