UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035985 |
|---|---|
| Receipt number | R000040988 |
| Scientific Title | Effect of kinesthetic illusion induced by visual stimulation in patients with stroke |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2020/08/25 09:07:08 |
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Basic information
Public title
Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Acronym
Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Scientific Title
Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Scientific Title:Acronym
Effect of kinesthetic illusion induced by visual stimulation in patients with 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 therapy with kinesthetic illusion induced by visual stimulation five days per week for two weeks on the 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
Magnetoencephalography
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
20 minutes for kinesthetic illusion induced by visual stimulation 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) ischemic or hemorrhagic stroke
2) more than 90 days after stroke onset
3) motor paresis on upper extremity
4) ability to flex fingers partially, inability to extend fingers
5) not severe contracture on finger joints
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 30 days
5) history of specific neurorehabilitation such as rTMS, tDCS, functional electrical stimilation, and repetitive facilitative exercise, and constraint induced movement therapy within 30 days
6) history of botulinum toxin injection or nerve block within 30 days
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Takahashi |
Organization
Hokuto Hospital
Division name
Department of Medical Technology
Zip code
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL
0155-48-8000
hokutopt.takahashi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Takahashi |
Organization
Hokuto Hospital
Division name
Department of Medical Technology
Zip code
Address
7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL
0155-48-8000
Homepage URL
hokutopt.takahashi@gmail.com
Sponsor or person
Institute
Hokuto Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokuto Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 25 | 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
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
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040988
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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