UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034031 |
|---|---|
| Receipt number | R000038796 |
| Scientific Title | Efficacy of brain-computer interface driven exoskeletal robot for hemiparesis after stroke. |
| Date of disclosure of the study information | 2018/09/04 |
| Last modified on | 2020/04/20 11:51:04 |
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Basic information
Public title
Efficacy of brain-computer interface driven exoskeletal robot for hemiparesis after stroke.
Acronym
Efficacy of brain-computer interface driven exoskeletal robot for hemiparesis after stroke.
Scientific Title
Efficacy of brain-computer interface driven exoskeletal robot for hemiparesis after stroke.
Scientific Title:Acronym
Efficacy of brain-computer interface driven exoskeletal robot for hemiparesis after stroke.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of brain-machine interface driven exoskeletal robot for upper extremity paresis after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Key secondary outcomes
other clinical evaluations, EEG, rsfMRI, Three-dimensional motion analysis, surface EMGs
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
A)The exoskeletal robot is driven regardless of event t-related desynchronization (ERD) during motor imagery. 100 times a day for 7 days.
B)The exoskeletal robot is driven by an event-related desynchronization (ERD) during motor imagery. 100 times a day for 7 days.
A)The exoskeletal robot is driven regardless of event t-related desynchronization (ERD) during motor imagery. 100 times a day for 7 days.
B)The exoskeletal robot is driven by an event-related desynchronization (ERD) during motor imagery. 100 times a day for 7 days.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) hemiparesis after stroke
2) first-ever stroke
3) more than 6 months after stroke onset
4) the score of SIAS is 4 or less
5) walking independently
Key exclusion criteria
1) severe comorbidity
2) cognitive deficit
3) difficulty in scanning MRI
4) ROM of shoulder flexion is less than 90 degrees
5) Ability to shoulder flexion to 90 degrees without elbow flexion
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Akaboshi |
Organization
Shonan Keiiku Hospital
Division name
Department of Rehabilitation Medicine
Zip code
252-0816
Address
4360 Endo, Fujisawa-city, Kanagawa Prefecture
TEL
0466480050
krugreims@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Shindo |
Organization
Shonan Keiiku Hospital
Division name
Department of Rehabilitation Medicine
Zip code
252-0816
Address
4360 Endo, Fujisawa-city, Kanagawa prefecture
TEL
0466480050
Homepage URL
krugreims@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics committee of Shonan Keiiku Hospital
Address
4360 Endo, Fujisawa-city, Kanagawa
Tel
0466480050
K-miyazaki@keiiku.gr.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 | 09 | Month | 04 | 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
2
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 | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038796
