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
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
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
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
