UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008468 |
|---|---|
| Receipt number | R000009958 |
| Scientific Title | Rnadomized control study of non-invasive brain-machine interface for upper extremity function among patients with chronic hemiparetic stroke |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2018/01/22 09:37:49 |
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Basic information
Public title
Rnadomized control study of non-invasive brain-machine interface for upper extremity function among patients with chronic hemiparetic stroke
Acronym
Brain-machine interface for upper extremity function among patients with chronic hemiparetic stroke
Scientific Title
Rnadomized control study of non-invasive brain-machine interface for upper extremity function among patients with chronic hemiparetic stroke
Scientific Title:Acronym
Brain-machine interface for upper extremity function among patients with chronic hemiparetic stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We study the effect of BMI training for upper extremity function among patients with chronic hemiparetic stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer upper extremity motor score
Motor activity log
Key secondary outcomes
EEG
Transcranial magnetic stimulation
Cerebral blood flow
Modified Ashworth scale
EMG
Motion analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Electrical orthosis moves paretic finger when ERD is detected during motor imagery
Interventions/Control_2
Electrical orthosis moves paretic finger at motor imagery
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
| 13 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Time from stroke onset over 6months
No severe cognitive dsfunction
Stroke Impairment Assessment Set position score>1
Stroke Impairment Assessment Set knee mouth score >2
Key exclusion criteria
Medical history of seizure or the other medical complication which inhibit to recruit this experiment.
Patients implanted pacemaker
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fujiwara |
Organization
Tokai University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
tofuji@xc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Meigen Liu |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0353633833
Homepage URL
meigenliukeio@me.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
慶應義塾大学病院（東京都）東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 20 | 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
| 2012 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009958
