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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026398
Receipt No. R000030330
Scientific Title Development of the device which generate voluntary movement to verify brain function
Date of disclosure of the study information 2017/03/06
Last modified on 2017/03/04

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Basic information
Public title Development of the device which generate voluntary movement to verify brain function
Acronym Development of the device which generate voluntary movement to verify brain function
Scientific Title Development of the device which generate voluntary movement to verify brain function
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Faculty science and engineering
Zip code
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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Faculty science and engineering
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 08 Day
Date of IRB
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

Other
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

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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