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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034892
Receipt No. R000039775
Scientific Title The effects of motor imagery trainig by EEG-feedback system in patients with medial medullary infarction
Date of disclosure of the study information 2018/11/14
Last modified on 2019/05/16

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Basic information
Public title The effects of motor imagery trainig by EEG-feedback system in patients with medial medullary infarction
Acronym Treatment of medial medullary infarction using motor imagery training
Scientific Title The effects of motor imagery trainig by EEG-feedback system in patients with medial medullary infarction
Scientific Title:Acronym Treatment of medial medullary infarction using motor imagery training
Region
Japan

Condition
Condition hemiplegic patients
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of rehabilitation using EEG-feedback system (iNems) for cerebrovascular disorder patients admitted to Watanabe Hospital
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer Assessment
Motor activity log
Numeric rating scale(numbness, sense of agency and sense of ownership)
The Bath CRPS Body Perception Disturbance Scale
Number of successful exercise images
Rang of motion of finger
Brain neural activity by electroencephalogram analysis
Key secondary outcomes Barthel Index

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 EEG-feedback system
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Cerebrovascular disorders patients(cerebral infarction)
Level 1 to 4 on upper limb BRS
Patient who able to keep sitting position by watching or self-reliance
Key exclusion criteria Severe aphasia, Severe dementia
Severe apraxia, Severe Agnosia
Visual impairment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Kodama
Organization Kyoto Tachibana University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code
Address 34 Yamada-cho, Oyake, Yamashina-ku, Kyoto
TEL 075-574-4312
Email kodama-t@tachibana-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Kodama
Organization Kyoto Tachibana University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code
Address 34 Yamada-cho, Oyake, Yamashina-ku, Kyoto
TEL 075-574-4312
Homepage URL
Email kodama-t@tachibana-u.ac.jp

Sponsor
Institute Kyoto Tachibana University
Institute
Department

Funding Source
Organization This study was funded by a JSPS KAKENHI Grant Number 18K10798
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2018 Year 11 Month 14 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 20 Day
Date of IRB
2018 Year 07 Month 11 Day
Anticipated trial start date
2018 Year 05 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospectively registered

Management information
Registered date
2018 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039775

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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