UMIN-CTR Clinical Trial

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
Last 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
1st 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