UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055087 |
|---|---|
| Receipt number | R000062930 |
| Scientific Title | Measurement of cerebral blood flow during immersive VR mirror therapy in healthy subjects |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/26 15:34:41 |
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Basic information
Public title
Measurement of cerebral blood flow during immersive VR mirror therapy in healthy subjects
Acronym
Measurement of cerebral blood flow during immersive VR mirror therapy in healthy subjects
Scientific Title
Measurement of cerebral blood flow during immersive VR mirror therapy in healthy subjects
Scientific Title:Acronym
Measurement of cerebral blood flow during immersive VR mirror therapy in healthy subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether immersive VR mirror therapy activates motor-related areas on the non-motor side in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in oxygenated hemoglobin concentration during task execution
Key secondary outcomes
Subjective assessment of whether the non-moving side felt movement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using immersive VR mirror therapy and conventional mirror therapy, participants performed right index finger tapping exercises five times for 30 seconds.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy subjects
Key exclusion criteria
Those who have been diagnosed with a neurological disease or disorder in the past
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Gomi |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Occupational Therapy
Zip code
286-8686
Address
Kozunomori, Narita City, Chiba
TEL
0476-20-7774
gomi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Gomi |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Occupational Therapy
Zip code
286-8686
Address
Kozunomori, Narita City, Chiba
TEL
0476-20-7774
Homepage URL
gomi@iuhw.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Yukihiro Gomi
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
国際医療福祉大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062930
