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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034404
Receipt No. R000039232
Scientific Title Evaluation of muscle stiffness using ultrasound elastography
Date of disclosure of the study information 2018/11/01
Last modified on 2019/04/09

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Basic information
Public title Evaluation of muscle stiffness using
ultrasound elastography
Acronym Evaluation of muscle stiffness using
ultrasound elastography
Scientific Title Evaluation of muscle stiffness using
ultrasound elastography
Scientific Title:Acronym Evaluation of muscle stiffness using
ultrasound elastography
Region
Japan

Condition
Condition none
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantification of the elasticity of the muscle stiffness using ultrasound elastography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantification of the elasticity of the biceps brachii using ultrasound elastography
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria healthy volunteer
Key exclusion criteria having neuromuscular disease
handedness with past disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Yamauchi
Organization Tohoku University
Division name Department of Anesthesia and Preoperative medicine
Zip code 980-8575
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL 022-717-7321
Email yamauchi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Eiko
Middle name
Last name Onishi
Organization Tohoku University
Division name Department of Anesthesia and Preoperative medicine
Zip code 9808574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL 022-717-7321
Homepage URL
Email e-onishi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Department of Anesthesia and Preoperative medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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
2018 Year 11 Month 01 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
2018 Year 10 Month 22 Day
Date of IRB
2018 Year 10 Month 22 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruit after approval of ethics committee

Management information
Registered date
2018 Year 10 Month 08 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039232

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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