UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024799 |
|---|---|
| Receipt number | R000028533 |
| Scientific Title | The sensory stimuli induced hemodynamic responses in the cerebral cortex during the rehabilitative task |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2016/11/11 12:29:05 |
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Basic information
Public title
The sensory stimuli induced hemodynamic responses in the cerebral cortex during the rehabilitative task
Acronym
The sensory stimuli induced cortical responses
Scientific Title
The sensory stimuli induced hemodynamic responses in the cerebral cortex during the rehabilitative task
Scientific Title:Acronym
The sensory stimuli induced cortical responses
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the sensory stimuli induced cortical hemodynamic responses during the rehabilitative motor task.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The hemodynamic responses by the near-infrared spectroscopy
Key secondary outcomes
The results of motor task and the subjective assessment of sensory stimuli
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The sensory stimuli during the motor task
Interventions/Control_2
The pseudo sensory stimuli during the motor task
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) healthy adults (20-29 years-old)
(2) voluntary participation by signboard
(3) obtaining the informed consent following the understanding of the research
Key exclusion criteria
(1) patient with orthopedic diseases or sensory dysfunctions related to the task-difficulties
(2) diagnosis experience of psychiatry or neurology
(3) student belonging to the researcher's class
(4) judgement of unsuitable by the principal investigator or researcher
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Urakawa Susumu |
Organization
Hiroshima Univ
Division name
Dept of Musculoskeletal Functional Research and Regeneration
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5430
urkawas@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Urakawa Susumu |
Organization
Hiroshima Univ
Division name
Dept of Musculoskeletal Functional Research and Regeneration
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5430
Homepage URL
urkawas@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Univ
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Univ
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
広島大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 16 | 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
| 2016 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028533
