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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005770
Receipt No. 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

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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
Email

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/
Email takizawa@biophilia.biz

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

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002811

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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