UMIN-CTR Clinical Trial

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
Last 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
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-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/icdr_e/ctr_view.cgi?recptno=R000020313