UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005770 |
|---|---|
| Receipt number | R000002811 |
| Scientific Title | The examination about the performance and safe operation of the Motivative exercise evaluation device |
| Date of disclosure of the study information | 2011/06/14 |
| Last modified on | 2011/07/01 18:34:23 |
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Basic information
Public title
The examination about the performance and safe operation of the Motivative exercise evaluation device
Acronym
Motivative exercise evaluation device test
Scientific Title
The examination about the performance and safe operation of the Motivative exercise evaluation device
Scientific Title:Acronym
Motivative exercise evaluation device test
Region
| Japan |
Condition
Condition
cerebrovascular disorder, after effect of cerebrovascular disorder, cerebrovascular occlusive disease, cerebrovascular dementia, chronic subdural hematoma, Parkinson disease, a malignant lymphoma, a bone joint disease, osteoporosis, rheumatoid arthritis, hemiplegia, renal dysfunction, renal insufficiency, angina, hypertension, acrocontracture, heart disease, myocardial infarction, heart failure, atrial fibrillation, cholelithiasis, diabetes, pneumonia, pulmonary emphysema, chronic bronchitis, a chronic respiratory failure, glaucoma, senile dementia
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The devices which enable passive and activated exercise for affected side by the self-action of an unaffected side were developed about the rehabilitation (reha) technique which is useful for life independence of elderly people. The evaluation device of it is needed to be developed from this exercise having been attained. Since development of Motivative excise evaluation device was finished, the examination about the performance and safe operation of the Motivative excise device is done.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The subjects' body temperature change before and after by using the developed device is measured and evaluated.
Key secondary outcomes
The permanence and practicality of evaluation devise for using three months and the reliability of it for the judgment about ambulatory ability.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The examination of leg function evaluation device between August 15 to November 15, 2009
The user of the specification special medical corporation Kigankai, Okamoto Hospital Outpatients Rehabilitation Center in the Oita Bungo-oono City
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The user of the specification special medical corporation Kigankai, Okamoto Hospital Outpatients Rehabilitation Center in the Oita Bungo-oono City
Key exclusion criteria
Any one who doesn't participate with the test and wants to defect it.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKIZAWA, Shigeo |
Organization
Biophilia Institute designated by the Ministry of Education, Culture, Sports, Science and Technology appointed research institution
Division name
Institute
Zip code
Address
4-24-5 Shonandai, Fujisawa-shi, Kanagawa-ken
TEL
0466-81-0204
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKIZAWA, Shigeo |
Organization
Biophilia Institute designated by the Ministry of Education, Culture, Sports, Science and Technology
Division name
Institute
Zip code
Address
7-5-4, Zengyo, Fujisawa-shi, Kanagawa-ken
TEL
0466-81-0204
Homepage URL
http://www.biophilia.biz/test01/
takizawa@biophilia.biz
Sponsor or person
Institute
Biophilia Institute designated by the Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The specification special medical corporation Kigankai, Okamoto Hospital
Name of secondary funder(s)
SFC Institute of 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
特定特別医療法人帰巌会岡本病院(The specification special medical corporation Kigankai, Okamoto Hospital)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000002811&language=J
Publication of results
Partially published
Result
URL related to results and publications
http://biophilia.biz/test01/
Number of participants that the trial has enrolled
Results
The training effect measurement device was used safely by subjects under the instruction of physical therapists for three months. The changes of body temperature were tested with SPSS for every use of the device, where no significant change was found. It shows that the exercise gave no strain to the users.
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 | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2011 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002811
| 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 |
