UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026896 |
|---|---|
| Receipt number | 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 17:00:13 |
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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
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
michiyukikawakami0212@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicien, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030856
