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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042350
Receipt No. 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 2020/11/04

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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
Email 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
Email satot@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
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
2020 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046831

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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