UMIN-CTR Clinical Trial

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 Takayuki Middle name Last name Kodama
Organization	Kyoto Tachibana University
Division name	Department of Physical Therapy, Faculty of Health Sciences
Zip code	607-8175
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 Takayuki Middle name Last name Kodama
Organization	Kyoto Tachibana University
Division name	Department of Physical Therapy, Faculty of Health Sciences
Zip code	607-8175
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	Kyoto Tachibana University Research Ethics Committee
Address	34 Yamada-cho, Oyake, Yamashina-ku, Kyoto
Tel	075-574-4186
Email	tec@tachibana-u.ac.jp

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	40
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	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	2021 Year 05 Month 03 Day

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