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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017525
Receipt No. 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

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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
Email 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
Email mizuno.katsuhiro@gmail.com

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

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020313

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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