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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033315
Receipt No. R000037976
Official scientific title of the study 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 2018/07/06

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Basic information
Official scientific title of the study Performance Evaluation Experiments of Gait Assistive Suit Using Pneumatic Artificial Rubber Muscle
Title of the study (Brief title) 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 4 channels)
Key secondary outcomes Measuring leg motion trajectories measured by an optical 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 10

Research contact person
Name of lead principal investigator Tetsuro Miyazaki
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Address 2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL 0352808163
Email tmiyazaki.bmc@tmd.ac.jp

Public contact
Name of contact person General affairs section
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Address 2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL 0352808003
Homepage URL
Email zaikensoumu.adm@cmn.tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.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


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