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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020405
Receipt No. R000023565
Scientific Title The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Date of disclosure of the study information 2016/01/05
Last modified on 2019/07/30

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Basic information
Public title The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Acronym The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Scientific Title The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Scientific Title:Acronym The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To consider impact of active and passive brain activation on cerebral blood flow and finger exercise performance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration of oxyhemoglobin during motor task
Key secondary outcomes Motor peformances(the number of motor task, the successful number of motor task, error ration of motor task, smoothness of hand during motor task)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Visit1:Motor task, Control(rest;2 minutes), Motor task
interval(at least a day)
Visit2: Motor task, Simple hand grasping exercise(2 minutes), Motor task
interval(at least a day)
Visit3: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
Interventions/Control_2 Visit1: Motor task, Control(rest;2 minutes), Motor task
interval(at least a day)
Visit2: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
interval(at least five days)
Visit3: Motor task, Simple hand grasping exercise(2 minutes), Motor task
Interventions/Control_3 Visit1: Motor task, Simple hand grasping exercise(2 minutes), Motor task
interval (at least a day)
Visit2: Motor task, Control(rest;2 minutes), Motor task
interval (at least a day)
Visit3:Motor task, Transcranial direct current stimulation(15 minutes), Motor task
Interventions/Control_4 Visit1: Motor task, Simple hand grasping exercise(2 minutes), Motor task
interval (at least a day)
Visit2: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
interval (at least five days)
Visit3: Motor task, Control(rest;2 minutes), Motor task
Interventions/Control_5 Visit1: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
interval (at least five days)
Visit2: Motor task, Control(rest;2 minutes), Motor task
interval (at least a day)
Visit3: Motor task, Simple hand grasping exercise(2 minutes), Motor task
Interventions/Control_6 Visit1: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
interval (at least five days)
Visit2: Motor task, Simple hand grasping exercise(2 minutes), Motor task
interval (at least a day)
Visit3: Motor task, Control(rest;2 minutes), Motor task
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria The dominant hand is right-handed.
Who consent is obtained in writing with respect to the participation of research.
Key exclusion criteria There is a history of neurological disorders, psychiatric disorders.
There is a history or current medical history of impaired cognitive function.
There is musculoskeletal disorders of the hand finger.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Sunagawa
Organization Hiroshima University Graduate School of Biomedical & Health Sciences
Division name Analysis & Control of Upper Extremity Function
Zip code
Address 1-2-3 Kasumi Hiroshima Japan
TEL 082-257-5455
Email torusuna@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Onishi
Organization Hiroshima University Graduate School of Biomedical & Health Sciences
Division name Analysis & Control of Upper Extremity Function
Zip code
Address 1-2-3 Kasumi Hiroshima Japan
TEL 082-257-5457
Homepage URL
Email m145422@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Graduate School of Biomedical & Health Sciences, Control of Upper Extremity Function
Institute
Department

Funding Source
Organization Grants in aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 01 Month 05 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 Completed
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
2015 Year 12 Month 14 Day
Anticipated trial start date
2016 Year 01 Month 05 Day
Last follow-up date
2017 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
2015 Year 12 Month 30 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023565

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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