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

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 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

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

Value
https://center6.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