UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042350 |
|---|---|
| Receipt number | R000046831 |
| Scientific Title | Quantitative analysis for Muscle Activity of Daily Living using PLLA |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2023/12/13 13:36:31 |
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Basic information
Public title
Basic Study about Correlation between PLLA and EMG wave pattern
Acronym
PLLA basic study
Scientific Title
Quantitative analysis for Muscle Activity of Daily Living using PLLA
Scientific Title:Acronym
ADL quantitative study
Region
| Japan |
Condition
Condition
Health Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We collect electromyographic data of the leg muscles synchronized with vibration data from the Achilles of healthy volunteers and analyze the correlation between the vibration waveform of the Achilles and the leg muscle radio wave shape.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the correlation between the vibration waveform of the Achilles and the leg muscle radio wave shape
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
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
Vibration measurement
Electromyography
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Self-determined individuals between the ages of 20 and 64 (of any gender)
(2)Persons who understand the purpose of this study and agree to participate in the study.
Key exclusion criteria
(1) Minors
(2) A person receiving treatment for a pre-existing disease in health care
(3) Those who are being monitored for a pre-existing disease in health care
(4) A person whose participation in research is deemed inappropriate by the researcher.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Iwase |
Organization
Saitama Medical University Hospital
Division name
Department of Emergency and Palliative Medicine
Zip code
3500495
Address
38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
TEL
049-276-1705
siwase@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Sato |
Organization
Saitama Medical University Hospital
Division name
Palliative Medicine
Zip code
3500495
Address
38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
TEL
049-276-1705
Homepage URL
satot@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
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
Institutional Review Board of Saitama Medical University
Address
38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
Tel
049-276-2143
rinri@saitama-med.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
| 2020 | Year | 11 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046831
