UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034031
Receipt No. 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 2019/09/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email krugreims@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.