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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032283
Receipt No. 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 2019/10/18

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

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 No longer recruiting
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
2019 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.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


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