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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name