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

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 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


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

Value
https://center6.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