UMIN-CTR Clinical Trial

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
Institute	Tokyo Medical and Dental University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037976