UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037606
Receipt number R000042881
Scientific Title Effect of use of a training machine with pneumatic artificial rubber muscles on muscle activity
Date of disclosure of the study information 2019/08/06
Last modified on 2019/08/06 16:17:46

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Basic information

Public title

Effect of use of a training machine with pneumatic artificial rubber muscles on muscle activity

Acronym

Effect of use of a training machine with pneumatic artificial rubber muscles on muscle activity

Scientific Title

Effect of use of a training machine with pneumatic artificial rubber muscles on muscle activity

Scientific Title:Acronym

Effect of use of a training machine with pneumatic artificial rubber muscles on muscle activity

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of muscle activity patterns that can be promoted by using a training device with pneumatic artificial rubber muscles

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle activity during use of the training machine

Key secondary outcomes

Posture during use of the training machine


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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Presentation of load by pneumatic artificial rubber muscles

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

60 years-old >

Gender

Male

Key inclusion criteria

Since the research assistant (male) may come into contact with the body of the participants (such as attaching electromyographic electrodes), the participants are limited to healthy males between the ages of 20 and 60.

Key exclusion criteria

For safety reasons, we exclude those who cannot use the training device in a stable posture and those who have a range of motion that is narrower than the range in which the device can move.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Toshihiro
Middle name
Last name Kawase

Organization

Tokyo Medical and Dental University

Division name

Institute of Biomaterials and Bioengineering

Zip code

101-0062

Address

2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo

TEL

03-5280-8163

Email

kawase.bmc@tmd.ac.jp


Public contact

Name of contact person

1st name Toshihiro
Middle name
Last name Kawase

Organization

Tokyo Medical and Dental University

Division name

Institute of Biomaterials and Bioengineering

Zip code

101-0062

Address

2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo

TEL

03-5280-8163

Homepage URL


Email

kawase.bmc@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Bridgestone Corporation

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

Bioethics Research Center, Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-4724

Email

info.bec@tmd.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

2019 Year 08 Month 06 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

Preinitiation

Date of protocol fixation

2019 Year 08 Month 06 Day

Date of IRB


Anticipated trial start date

2019 Year 10 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



Management information

Registered date

2019 Year 08 Month 06 Day

Last modified on

2019 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042881


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name