UMIN-CTR Clinical Trial

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