UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013511 |
|---|---|
| Receipt number | R000015786 |
| Scientific Title | Examination about the behavior analysis using the inertial measurement unit. |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2015/01/23 15:25:30 |
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Basic information
Public title
Examination about the behavior analysis using the inertial measurement unit.
Acronym
Examination about the behavior analysis using the inertial measurement unit.
Scientific Title
Examination about the behavior analysis using the inertial measurement unit.
Scientific Title:Acronym
Examination about the behavior analysis using the inertial measurement unit.
Region
| Japan |
Condition
Condition
The patient whom ability to move is limited
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
establish a system inspecting a rehabilitation effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement rate of true movement and the judgment result
Key secondary outcomes
amount of activity
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
puts on the unit and works
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) ambulatory patient in Saku central hospital.
2) cerebrovascular. obstacle of the exercise function. disuse syndrome
3) The patient whom ability to move is limited.
4) J and A rank in the degree of independent living
5)stable disease
6)There is not a feeling of resistance for a device.
7)An agreement is provided
Key exclusion criteria
1) A device is buried in the body
2) metallic allergy
3)a desperately ill patient
4) Patient with the danger to be upset
5) Patient who has difficulty in wearing of the unit.
6) Inappropriate patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Fujii |
Organization
Saku central hospital
Division name
Dep of rehabilitation
Zip code
Address
197 Usuda,Saku,Nagano
TEL
0267-82-3131
Hiro-fj@hh.iij4u.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Hokari |
Organization
Seiko epson corporation
Division name
Corporate research & development Div
Zip code
Address
281 Fujimi,Fujimi-machi,Suwa-gun,Nagano
TEL
0266-61-0669
Homepage URL
hokari.ryuji@exc.epson.co.jp
Sponsor or person
Institute
Seiko epson corporation
Institute
Department
Personal name
Funding Source
Organization
Seiko epson corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
佐久総合病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2014 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015786
