UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032283
Receipt number R000035017
Scientific Title The effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training in patients with severe hemiparetic stroke
Date of disclosure of the study information 2018/04/17
Last modified on 2020/04/20 11:43:21

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Basic information

Public title

The effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training in patients with severe hemiparetic stroke

Acronym

The effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training in patients with severe hemiparetic stroke

Scientific Title

The effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training in patients with severe hemiparetic stroke

Scientific Title:Acronym

The effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training in patients with severe hemiparetic stroke

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of combined therapy with kinesthetic illusion induced by visual stimulation and brain machine interface training five days per week for two weeks on the severe paretic upper extremity after stroke.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of upper extremity function (Fugl-Meyer Assessment, etc)

Key secondary outcomes

Electroencephalogram, resting-state fMRI


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

1) 20 minutes for kinesthetic illusion induced by visual stimulation
2) 40 minutes for brain machine interface training
1)+2) five days per week for two weeks

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) ischemic or hemorrhagic stroke
2) first-ever stroke
3) more than 90 days after stroke onset
4) motor paresis on upper extremity
5) ability to flex fingers partially, inability to extend fingers
6) not severe contracture on finger joints
7) ability to walk outside for 10 minute (with or without any assistance)
8) Living at home

Key exclusion criteria

1) severe medical comorbidities unable to perform the therapy
2) severe cognitive or psychiatric disorder
3) pacemaker or implantable cardioverter defibrillators
4) history of epilepsy within 90 days
5) history of specific neurorehabilitation such as rTMS, tDCS, functional electrical stimilation, and repetitive facilitative exercise, and constraint induced movement therapy within 90 days
6) history of botulinum toxin injection or nerve block within 90 days
7) inability to perform electroencephalogram due to skin condition or skull issue

Target sample size

15


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

0466-48-0050

Email

redstar@td6.so-net.ne.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

0466-48-0050

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

AMED

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

0466-48-0050

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 04 Month 17 Day


Related information

URL releasing protocol

https://www.abstractsonline.com/pp8/#!/4649/presentation/21082

Publication of results

Partially published


Result

URL related to results and publications

https://www.abstractsonline.com/pp8/#!/4649/presentation/21082

Number of participants that the trial has enrolled

14

Results

FMA and MAS for upper extremity significantly improved after the intervention.The insula lobe had significantly higher connectivity to BA6 in the involved hemisphere, and BA44 and rolandic operculum in the uninvolved hemisphere after the intervention. rsFC of BA6 in the involved hemisphere and the fusiform gyrus in the involved and uninvolved hemisphere were enhanced after the intervention.

Results date posted

2019 Year 10 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Fourteen patients with chronic stroke

Participant flow

We applied a treatment package, which was composed of KiNvis therapy with neuromuscular electrical stimulation, BMI therapy, and exercise for upper extremity for a total of 10 days.

Adverse events

None

Outcome measures

FMA,MAS,rsfMRI

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 15 Day

Date of IRB

2017 Year 11 Month 02 Day

Anticipated trial start date

2017 Year 12 Month 18 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry

2018 Year 10 Month 17 Day

Date trial data considered complete

2018 Year 10 Month 17 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 04 Month 17 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=R000035017


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name