UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033315
Receipt number R000037976
Scientific Title Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle
Date of disclosure of the study information 2018/07/06
Last modified on 2020/07/07 10:24:38

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Basic information

Public title

Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle

Acronym

Performance Evaluation of Gait Assistive Suit

Scientific Title

Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle

Scientific Title:Acronym

Performance Evaluation of Gait Assistive Suit

Region

Japan


Condition

Condition

Gait training on a treadmill

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Performance evaluation of the proposed gait assistive suit

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measuring leg EMGs (calf, thigh, total of 4 to 8 channels)

Key secondary outcomes

Measuring leg motion trajectories measured by a motion capture system


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

The external force generated by the gait assistive suit

The using time is about 1 hour.

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

Because the assistant (male) may contact the body of the subject (support for falling prevention, set the electrode for myoelectric measurement etc.), research subjects are limited to 20 to 60 years old healthy male who can walk on their own.

Key exclusion criteria

Those who have hurdles to walking are excluded.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Miyazaki

Organization

Tokyo Medical and Dental University

Division name

Institute of Biomaterials and Bioengineering

Zip code

1010062

Address

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

TEL

0352808163

Email

tmiyazaki.bmc@tmd.ac.jp


Public contact

Name of contact person

1st name Institute of Biomaterials and Bioengineering
Middle name
Last name General affairs section

Organization

Tokyo Medical and Dental University

Division name

Institute of Biomaterials and Bioengineering

Zip code

1010062

Address

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

TEL

0352808003

Homepage URL


Email

zaikensoumu.adm@cmn.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

Tokyo Medical and Dental University

Address

2-3-10 Kanda Surugadai, Chiyoda-ku

Tel

0352808003

Email

zaikensoumu.adm@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

2018 Year 07 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

5

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

Completed

Date of protocol fixation

2018 Year 07 Month 06 Day

Date of IRB

2019 Year 08 Month 28 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2020 Year 07 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 06 Day

Last modified on

2020 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name