UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018408 |
|---|---|
| Receipt number | R000021311 |
| Scientific Title | Development of quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2020/01/29 07:50:21 |
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Basic information
Public title
Development of quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor
Acronym
Development of quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor
Scientific Title
Development of quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor
Scientific Title:Acronym
Development of quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor
Region
| Japan |
Condition
Condition
respiratory dysfunction
Classification by specialty
| Medicine in general | Pneumology | Neurology |
| Surgery in general | Gastrointestinal surgery | Chest surgery |
| Anesthesiology | Neurosurgery | Cardiovascular surgery |
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop the quantitative method of thoracoabdominal movement using Fiber grating(FG) sensor and validate the efficacy it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
reliability(intraclass correlation coefficient), validity(Pearson product-moment correlation coefficient), responsiveness(standardized response means)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of thoracoabdominal movement using Fiber grating(FG) sensor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects and patients agreed with this research
Key exclusion criteria
1)pulse rate at rest within 120/min
2)diastolic blood pressure within 120mmHg
3)systolic blood pressure within 200mmHg
4)present exertional angina pectoris
5)myocardial infarct within 1 month
6)present congestive heart failure
7)severe arhythmia except for atrial fibrillation
8)present palpitation and shortness of breath
9)marked body motion in supine position
10)infectious disorder need for isolation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Liu |
Organization
Keio university school of medicine
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
106 White forest, Higashi, Hasuda-shi, Saitama 349-0111, Japan
TEL
0333531211
s03526fl@gmail.com
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Liu |
Organization
National Higashi-Saitama Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3490196
Address
4147 Kurohama, Hasuda-shi, Saitama 349-0196, Japan
TEL
048-768-1161
Homepage URL
s03526fl@gmail.com
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
East Saitama Hospital
Address
4147, Kurohama,Hasuda city, Saitama
Tel
048-768-1161
ogata-neu@umin.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://rc.rcjournal.com/content/early/2016/12/27/respcare.04913
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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021311
| Research Plan | |
|---|---|
| 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 |
