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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029090
Receipt No. R000033269
Scientific Title The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Date of disclosure of the study information 2017/09/15
Last modified on 2019/03/13

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Basic information
Public title The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Acronym The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Scientific Title The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Scientific Title:Acronym The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Region
Japan

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

Objectives
Narrative objectives1 The first purpose is to determine the degree of difficulty of the antagonistic exercises
The second purpose is determine a difference of the prefrontal cerebral blood flow of subjects during each tasks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the number of the errors
Key secondary outcomes prefrontal cerebral blood flow
Subjective degree of difficulty (Visual Analog Scale)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 antagonistic exercise
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
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
The person whom a study person in charge judged to be inadequate as subjects
Target sample size 27

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 3900821
Address 3-1-1 asahi matsumoto nagano japan
TEL 0263-37-2404
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 3900821
Address 3-1-1 asahi matsumoto nagano japan
TEL 0263-37-2404
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 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
2017 Year 09 Month 15 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 15 Day
Date of IRB
2017 Year 09 Month 04 Day
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
2020 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
2017 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033269

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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