UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057279 |
|---|---|
| Receipt number | R000065474 |
| Scientific Title | Elucidation of Cerebral Hemodynamic Responses Induced by Mirror Visual Feedback Combined with Electromyography-Evoked Stimulation |
| Date of disclosure of the study information | 2025/03/13 |
| Last modified on | 2025/09/12 10:17:15 |
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Basic information
Public title
Elucidation of Cerebral Hemodynamic Responses Induced by Mirror Visual Feedback Combined with Electromyography-Evoked Stimulation
Acronym
Elucidation of Cerebral Hemodynamic Responses Induced by Mirror therapy Combined with Electrostimulation
Scientific Title
Elucidation of Cerebral Hemodynamic Responses Induced by Mirror Visual Feedback Combined with Electromyography-Evoked Stimulation
Scientific Title:Acronym
Elucidation of Cerebral Hemodynamic Responses Induced by Mirror therapy Combined with Electrostimulation
Region
| Japan |
Condition
Condition
cerebrovascular accident
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the short-term effects of visual input through a mirror and afferent input through electrical stimulation on brain function activation in stroke patients using a functional near-infrared spectroscopy (fNIRS) device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygenated hemoglobin concentration
Key secondary outcomes
Brunnstrom stage, Modified Ashworth Scale, Mini-Mental Status Examination (MMSE) score, Visual Analogue Scale (VAS), Action Research Arm Test (ARAT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
One day intervention, 60second wrist dorsiflexion movements(18 sessions).
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
At least six months have passed since the onset of ischemic or hemorrhagic stroke.
The Brunnstrom stage is III or higher in both the proximal and distal parts of the upper limb.
There is no excessive spasticity in any joint of the affected upper limb (Modified Ashworth Scale (MAS) < 3).
There is no severe cognitive impairment (Mini-Mental Status Examination (MMSE) score > 24 or Hasegawa Dementia Scale-Revised (HDS-R) > 24).
There is no severe visual or visuoperceptual impairment (National Institutes of Health Stroke Scale (NIHSS) best gaze and visual subtest scores = 0).
Key exclusion criteria
A history of neurological, neuromuscular, orthopedic, or psychiatric disorders other than stroke.
Participation in other experimental rehabilitation or pharmacological studies concurrently with this study.
A recorded recurrence of stroke or seizure within the past month.
Individuals with impairments that affect seated posture maintenance or bilateral upper limb movement.
Other cases deemed unsuitable as subjects by the principal investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Inagaki |
Organization
Faculty of Health Sciences, Graduate School of Health Sciences, Hokkaido University
Division name
Field of Rehabilitation Science
Zip code
0600812
Address
Kita 12-jo Nishi 5-chome (D511), Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117063335
y.inagaki@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Inagaki |
Organization
Faculty of Health Sciences, Graduate School of Health Sciences, Hokkaido University
Division name
Field of Rehabilitation Science
Zip code
0600812
Address
Kita 12-jo Nishi 5-chome (D511), Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117063335
Homepage URL
y.inagaki@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Yuji Inagaki
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Graduate School of Health Sciences, Hokkaido University
Address
Kita 12-jo Nishi 5-chome , Kita-ku, Sapporo, Hokkaido, Japan
Tel
0117063315
shomu@hs.hokudai.ac.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
北海道医療大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065474
