UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006559 |
|---|---|
| Receipt number | R000006962 |
| Scientific Title | Brain activity Measurement at performing motivative exercise and passive exercise by functional magnetic resonance imaging |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2011/10/17 19:22:45 |
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Basic information
Public title
Brain activity Measurement at performing motivative exercise and passive exercise by functional magnetic resonance imaging
Acronym
Evaluation of the Motivative Exercise by fMRI
Scientific Title
Brain activity Measurement at performing motivative exercise and passive exercise by functional magnetic resonance imaging
Scientific Title:Acronym
Evaluation of the Motivative Exercise by fMRI
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
Large of the brain active region between the motivative exercise and passive exercise to legs/leg for 30 seconds respectively.
Key secondary outcomes
The task is passive ROM exercise in paralytic ankle joint by physical therapists and motivative exercise in both ankles with non-paralytic side simultaneously. 1 cycle consists 45seconds rest, 30s task and 30s rest. Data of 3 cycle trials are analyzed automatically using SIGNA, ECITE HDx 3.0T by GM Company.
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
Passive ROM exercise in paralytic ankle joint by physical therapist and motivative exercise by Pata in both ankles simultaneously to induce activation by leading of the non-paralytic side ankle for 30 seconds respectively.
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 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- 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
0466-81-0204
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
Sofukai Foundation, Okayama Rehabilitation Hospital
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
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 旭東病院（岡山県）
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/ab19.pdf
Number of participants that the trial has enrolled
Results
In the brain activity of all the subjects analyzed by fMRI, activated area was wider in the motivative exercise for dorsiflexion and plantar flexion exercise, than passive dorsiflexion and plantar flexion ROM exercise to paralytic limb only. Also, activation of some affected brain area were seen.
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 | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | 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
| 2012 | Year | 10 | 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=R000006962
