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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014574
Receipt No. R000016910
Scientific Title Development of rehabilitation system with brain-machine interface for severe hemiplegic patients.
Date of disclosure of the study information 2014/07/16
Last modified on 2015/06/23

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Basic information
Public title Development of rehabilitation system with brain-machine interface for severe hemiplegic patients.
Acronym Development of rehabilitation system with brain-machine interface for severe hemiplegic patients.
Scientific Title Development of rehabilitation system with brain-machine interface for severe hemiplegic patients.
Scientific Title:Acronym Development of rehabilitation system with brain-machine interface for severe hemiplegic patients.
Region
Japan

Condition
Condition cerebral stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare performance and safty between pre-existing BMI rehabilitation system and newly developed one.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Impedance between electrode and skin.
Detection rate of event-related desynchronization.
A questionnaire about subjective avalability.
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We detect ERD wile participants imagine to extend and flex their own fingers. When we can detect effective ERD,we drive electrical brace to extend their fingers.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Healty controls and first-ever stroke patients.
Key exclusion criteria recurrence of stroke
Target sample size 17

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Meigen Liu
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Email meigenliukeio@mac.com

Public contact
1st name of contact person
1st name
Middle name
Last name Katsuhiro Mizuno
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35, Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Homepage URL
Email mizuno.katsuhiro@gmail.com

Sponsor
Institute Department of Rehabilitation Medicine, Keio University, School of Medicine
Institute
Department

Funding Source
Organization Panasonic Corporation
Eco Solutions Company
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
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
2014 Year 07 Month 16 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 Completed
Date of protocol fixation
2014 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
2015 Year 01 Month 26 Day
Date of closure to data entry
2015 Year 01 Month 26 Day
Date trial data considered complete
2015 Year 01 Month 26 Day
Date analysis concluded
2015 Year 01 Month 26 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 16 Day
Last modified on
2015 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016910

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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