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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006559
Receipt No. 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

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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
Email

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/
Email takizawa@biophilia.biz

Sponsor
Institute Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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