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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037149
Receipt No. R000040809
Scientific Title The relationship between the corticospinal excitability during the Mirror Therapy and the motor imagery ability
Date of disclosure of the study information 2019/06/24
Last modified on 2020/04/27

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Basic information
Public title The relationship between the corticospinal excitability during the Mirror Therapy and the motor imagery ability
Acronym The relationship between the corticospinal excitability during the Mirror Therapy and the motor imagery ability
Scientific Title The relationship between the corticospinal excitability during the Mirror Therapy and the motor imagery ability
Scientific Title:Acronym The relationship between the corticospinal excitability during the Mirror Therapy and the motor imagery ability
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, it is intended that we determine association with the individual exercise image ability in healthy adults and the excitability of the corticospinal tract at mirror therapy practice.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motor evoked potential by the transcranial magnetic stimulation
Key secondary outcomes Motor image ability
Subjective evaluation of the illusion (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
Device,equipment
Interventions/Control_1 We stimulate the primary motor area of the contralateral finger in TMS in a timing to conduct finger exercise in Mirror Box and measure motor evoked potential of the contralateral finge. After measurement, we evaluate the subjective illusion at Mirror Therapy and motor imagery ability.
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 We intend for a healthy subject meeting all the following criteria for selection.
(1) We have the exercise capacity that can conduct a problem.
(2) Age is a person 20 years or older at the agreement acquisition
(3) The person that a written agreement was obtained based on the free will of the person after having received enough explanation on participating to this study.
Key exclusion criteria We intend for a healthy subject corresponding to none of the following exclusion criteria.
(1) A person with a history of the disease of the central nerve disorder.
(2) In addition, 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 Jun
Middle name
Last name Iwanami
Organization SHINSHU UNIVERSITY
Division name School of health Science, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matumoto, Nagano, JAPAN
TEL 0263372406
Email iwanami@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Iwanami
Organization SHINSHU UNIVERSITY
Division name School of health Science, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matumoto, Nagano, JAPAN
TEL 0263372406
Homepage URL
Email iwanami@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
Address 3-1-1, Asahi, Matumoto, 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
2019 Year 06 Month 24 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
2019 Year 02 Month 05 Day
Date of IRB
2019 Year 02 Month 05 Day
Anticipated trial start date
2019 Year 09 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 06 Month 24 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040809

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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