UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the device which generate voluntary movement to verify brain function
Title of the study (Brief title)	Development of the device which generate voluntary movement to verify brain function
Region	Japan

Condition
Condition	stroke
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of reproducibility of walking in lower limb exercise using device
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motion capture
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	The subjects carries out the three tasks shown below in clinical trial once. The task is carried out in order. 1.After resting for 3 seconds, walking normally for 10 steps. 2.Attaching the device to the foot, moving the lower limbs symmetrically for 10 steps after resting for 3 seconds. 3.Attaching the device to the foot, moving the lower limbs symmetrically for 10 steps with one leg supported by passive support, moving the other foot only after resting for 3 seconds.
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	23 years-old >=
Gender	Male
Key inclusion criteria	Healthy adults
Key exclusion criteria	1.It is difficult to walk normally 2.There are obstacles affecting movement of lower limbs 3.Pain and injury in each joint / muscle of the foot 4.There is inflammation in the attached part of the device
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyasu Iwata
Organization	Waseda university
Division name	Faculty science and engineering
Address	27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	Hiroyasu Iwata
Organization	Waseda university
Division name	Faculty science and engineering
Address	27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda university
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
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	2017 Year 03 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 06 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	2017 Year 03 Month 04 Day
Last modified on	2017 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030330