UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2020/04/20 (Ver. 8) |
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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 | |
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| Condition | ||
| Condition | stroke | |
| Classification by specialty |
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| 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 |
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| 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 |
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| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
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| Interventions/Control_7 | ||
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| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 15 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Baseline Characteristics | Fourteen patients with chronic stroke |
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| 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. |
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| Adverse events | None |
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| Outcome measures | FMA,MAS,rsfMRI |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035017 |
