UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014574 |
|---|---|
| Receipt number | 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 11:12:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
meigenliukeio@mac.com
Public contact
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
mizuno.katsuhiro@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016910
