UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006562 |
|---|---|
| Receipt number | R000006963 |
| Scientific Title | Brain activation evaluation of the motivative exercise and passive exercise by comparing the fMRI results to the fNIRS results |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2011/10/17 20:19:12 |
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Basic information
Public title
Brain activation evaluation of the motivative exercise and passive exercise by comparing the fMRI results to the fNIRS results
Acronym
Motivative Exercise comparing test of fMRI to fNIRS
Scientific Title
Brain activation evaluation of the motivative exercise and passive exercise by comparing the fMRI results to the fNIRS results
Scientific Title:Acronym
Motivative Exercise comparing test of fMRI to fNIRS
Region
| Japan |
Condition
Condition
Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Metatypical low back pain, Spondylosis deformans, Gonarthrosis, Fracture of femoral neck, After prosthesis replacement, Lumbar compression fracture, Spinal compression fracture, Both knee contractures, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Dementia, Disuse syndrome, Locomotive Syndrome
Classification by specialty
| Geriatrics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze chronologically the activity change of the brain damaged part of the patient at the time of rehabilitation only with fNIRS, easy system of measuring brain activity of rehabilitation in motion by the correlation analysis between outputs of fMRI and NIRS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
The reliability of activation status evaluation in motor area of the cerebral cortex analyzed by fNIRS is evaluated by imaging region from fMRI data which is projected on a two-dimensional surface of fNIRS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The Motivative exercise and Passive exercise to legs/leg for 30 seconds respectively. The fNIRS test carried out on March 24-27 and the fMRI test did on April 15-27, 2010.
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The outpatient of the Okayama Rehabilitation Hospital Rehabilitation, Day Care who gave the informed consent for the study.
Key exclusion criteria
The outpatient who did not want to join the study.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taki TAKIZAWA, Shigeo |
Organization
Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology
Division name
Research institute
Zip code
Address
4-24-5 Shonandai, Fujisawa-shi, Kanagawa
TEL
0466-81-0204
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taki TAKIZAWA, Shigeo |
Organization
Biophilia Institute,designated by the Ministry
Division name
Research institute
Zip code
Address
4-24-5 Shonandai, Fujisawa-shi, Kanagawa-ken
TEL
0466-90-4500
Homepage URL
http://www.biophilia.biz/test02/
takizawa@biophilia.biz
Sponsor or person
Institute
Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Foundation Sohuukai Okayama rehabilitation hospital
Name of secondary funder(s)
Tanaka Laboratory,
Department of Applied Physics and Physico-Informatics, Faculty of Science and Technology, Keio University
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
財団法人操風会岡山リハビリテーション病院（岡山県）、財団法人操風会岡山旭東病院（岡山県）、慶應義塾大学 理工学部 物理情報工学科 田中研究室(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.rehabil.uni.opole.pl/doc/ab17.pdf
Number of participants that the trial has enrolled
Results
This result shows that the position of mapped region from fMRI corresponds to that of the active region on a two-dimensional surface of fNIRS image. A possibility of correlating was suggested because the motor area is being activated similarly.
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
| 2009 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 17 | Day |
Last modified on
| 2011 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006963
| Research Plan | |
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| 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 |
