UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034892
Receipt number 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 2021/05/03 12:26:50

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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 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 or person

Institute

Kyoto Tachibana University

Institute

Department

Personal name



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

Value
https://center6.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