UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017525 |
|---|---|
| Receipt number | R000020313 |
| Scientific Title | Development of the robotic device driven by brain-machime ineterface (BMI) and validation of its effect on patients with hemiplegia. |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2019/03/28 14:34:33 |
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Basic information
Public title
Development of the robotic device driven by brain-machime ineterface (BMI) and validation of its effect on patients with hemiplegia.
Acronym
Study of BMI robot
Scientific Title
Development of the robotic device driven by brain-machime ineterface (BMI) and validation of its effect on patients with hemiplegia.
Scientific Title:Acronym
Study of BMI robot
Region
| Japan |
Condition
Condition
cerebral stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop the robotic rehabilitation device drived by BMI and validate the efficacy of it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
function of upper extrimity
Key secondary outcomes
simple reaction time, electromyography, motor evoked potential, motion analysis, MAL, NIRS, EEG
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ROM excersise of shoulder joint assisted by the BMI robot
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Stroke patients with hemiplagia
2. A patient can elevate shoulder more than 30 degrees without pain.
3. The point of knee-mouth test of SIAS is below 4 point.
4. A patient do not have severe cognitive dysfunction and/or aphasia and he/she can understand the purpose of this study.
Key exclusion criteria
1.A patient with spontaneous pain, infrlammation,or inpingiment in shoulder joint.
2.Past history of dislocation, flacture,or ligament injury.
3.A patient with consciousnes disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 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-ku, Tokyo
TEL
03-5363-3833
mizuno.katsuhiro@gmail.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-ku, 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
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Sanatorium Tamazenshoen
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
| 2015 | Year | 05 | Month | 12 | 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
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020313
