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
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
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
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
