UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020405 |
|---|---|
| Receipt number | 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 13:32:54 |
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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
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
m145422@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Graduate School of Biomedical & Health Sciences, Control of Upper Extremity Function
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023565
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
