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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026896
Receipt No. R000030856
Scientific Title Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Date of disclosure of the study information 2017/04/10
Last modified on 2019/04/05

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Basic information
Public title Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Acronym Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Scientific Title Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Scientific Title:Acronym Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess Effect of brain machine interface therapy on lower extremity motor function of patients with hemiplegia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Electroencephalograms
Surface electromyograms
Lower extremity motor function
Key secondary outcomes Motor evoked potentials induced by Transcranial magnetic stimulation or peripheral nerve stimulation
Motion analysis

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 Visual and kinesthetic feedback depending on brain activity (1-10 days)
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) The time from stroke longer than 180 days
(2) Stroke patients with hemiplegia
(3) Stroke Impairment Assessment Set Foot Pat score > 1
(4) Passive range of motion of the ankle dorsiflexion > 0 degree
(5) The ability to gait without physical assistance in daily life (the use of a cane and a brace does not matter)
Key exclusion criteria (1) Contraindication to the exercise for severe heart, lung and other disease
(2) Contraindication to electric muscle stimulation
(3) Patients who can not record electroencephalogram because of epilepsy or trauma injury.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawakami Michiyuki
Organization Keio University School of Medicine, Tokyo
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Email michiyukikawakami0212@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kawakami Michiyuki
Organization Keio University School of Medicine, Tokyo
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Homepage URL
Email michiyukikawakami0212@yahoo.co.jp

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

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Brain Robot Interface Computational Neuroscience Laboratories, Advanced Telecommunications Research Institute International
Department of Biosciences and informatics, Keio University School of Science and Engineering
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 慶應義塾大学 (東京都)、慶應義塾大学附属病院 (東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 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
2017 Year 04 Month 07 Day
Date of IRB
2017 Year 04 Month 11 Day
Anticipated trial start date
2017 Year 04 Month 12 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 07 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030856

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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