UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating how a walking assist suit using pneumatic artificial rubber muscles effects the gait of the wearer
Title of the study (Brief title)	Evaluation of a walking assist suit
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, a participant wears a walking assist suit driven by pneumatic artificial rubber muscles. The participant's gait is measured to evaluate the effects of the assist suit to the wearer's gait. The measured data may used for developing better control algorithm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	The experiment evaluates how the wearer's gait, such as joint angle, is changed by the assist suit.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A participant wears the assist suit, while the assist control is active
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	Healthy people, who have no disability in walking
Key exclusion criteria	People who have disability in walking
Target sample size	10

Research contact person
Name of lead principal investigator	Takahiro Kanno
Organization	Tokyo Medical and Dental University
Division name	Institute of Biomaterials and Bioengineering
Address	2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-5280-8163
Email	kanno.bmc@tmd.ac.jp

Public contact
Name of contact person	Takahiro Kanno
Organization	Tokyo Medical and Dental University
Division name	Institute of Biomaterials and Bioengineering
Address	2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-5280-8163
Homepage URL
Email	kanno.bmc@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	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 08 Month 25 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027385