UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037149 |
|---|---|
| Receipt number | 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 | 2023/06/27 15:29:59 |
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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
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
iwanami@shinshu-u.ac.jp
Sponsor or person
Institute
SHINSHU UNIVERSITY
Institute
Department
Personal name
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
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
信州大学（長野県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Completed
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 27 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040809
