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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036160
Receipt No. R000041162
Scientific Title The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Date of disclosure of the study information 2019/03/11
Last modified on 2019/03/11

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Basic information
Public title The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Acronym The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Scientific Title The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Scientific Title:Acronym The effect of difference in cognitive loading amount of antagonism exercises on event related potential P300
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the cognitive load of antagonistic exercises using event related potential P300
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amplitude of P300
Key secondary outcomes Latency of P300
Reaction time to Odd-ball task
Number of correct responses to Odd-ball task
Number of errors in antagonism exercises
Subjective difficulty index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 antagonistic exercise (Complex task) and Odd ball task
Interventions/Control_2 antagonistic exercise (Simple task) and Odd ball task
Interventions/Control_3 Odd ball task
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Person with the exercise capacity that can conduct a problem
Age is a person 20 years or older at the person agreement acquisition with the exercise capacity that can conduct a problem
The person that the agreement of the study was obtained
Key exclusion criteria A person with a history of the disease of the central nerve disorder
A person who have skin rash with alcohol
Target sample size 31

Research contact person
Name of lead principal investigator
1st name akira
Middle name
Last name sagari
Organization Shinshu University
Division name Division of Occupational Therapy School of Health Science
Zip code 3900861
Address 3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL 09079247401
Email sagaria@shinshu-u.ac.jp

Public contact
Name of contact person
1st name akira
Middle name
Last name sagari
Organization Shinshu University
Division name Division of Occupational Therapy School of Health Science
Zip code 3900861
Address 3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL 0263372404
Homepage URL
Email sagaria@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinshu University School of Medicine Ethics Review Board
Address 3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
Tel 0263372572
Email mdrinri@shinshu-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
2019 Year 03 Month 11 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
2019 Year 03 Month 05 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 10 Month 01 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
2019 Year 03 Month 11 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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