UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006563 |
|---|---|
| Receipt number | R000006965 |
| Scientific Title | Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient rehabilitation facilities) |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2011/10/17 19:23:48 |
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Basic information
Public title
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient rehabilitation facilities)
Acronym
Legs motivative exercise test by fNIRS (OpRF)
Scientific Title
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient rehabilitation facilities)
Scientific Title:Acronym
Legs motivative exercise test by fNIRS (OpRF)
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
Many examples of re-acquired walking were seen by enforcing the methodical autonomous rehabilitation (Takizawa Method by US patent) which made the Motivative exercise the core. In order to clarify mechanism of the method which has realized overcoming the disabilities, the activation situation of a brain function is investigated and we verify whether the Motivative exercise can be substituted for the passive exercise.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Comparison of changes of the oxyhemoglobin with the time of rest and task of the passive exercise and motivative exercise.
Key secondary outcomes
The FOIRE-3000 by Shimazu Corporation is used for fNIRS test. The 14 sets of Light Sources and Detectors measure 45 channels. The Light Sources No. 7 (middle of a channel 10-23) is set at the Center crown of head (Cz) for the measurement. We make a task cycle for each patient, which is 20 seconds rest from a start - 30 seconds task - 20 seconds rest, and performed three cycles. Evaluation is performed by the load average of 3 cycles exercise.
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The Motivative exercise and Passive exercise to legs/leg for 30 seconds respectively. It carried out on December 8-10, 2009
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The outpatient of Medical Corporation Tachibana Orthopedics Rehabilitation Day Care who gave us the informed consent for the study.
Key exclusion criteria
The outpatient who did not want to join the study.
Target sample size
12
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- ken
TEL
0466-90-4500
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taki TAKIZAWA, Shigeo |
Organization
Biophilia Institute,designated by the Ministry of Education, Culture, Sports, Science and Technology
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
Biophilia Institute, designated Institute by 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
Medical corporation Tachibana orthopedic rehabilitation facility for Outpatient
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
医療法人社団立花整形外科通所リハビリテーション事業所（兵庫県）
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/ab18.pdf
Number of participants that the trial has enrolled
Results
The result shows that the motivative exercise influences brain activity in the larger range than the passive exercise which a physiotherapist performs (P=0.000).
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
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | 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=R000006965
