UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051948 |
|---|---|
| Receipt number | R000059286 |
| Scientific Title | Effects of visually induced self-motion illusion using a 360-degree camera in combination with VR technology |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/08/19 10:54:21 |
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Basic information
Public title
Effects of visually induced self-motion illusion using a 360-degree camera in combination with VR technology
Acronym
Effects of visually induced self-motion illusion using a 360-degree camera in combination with VR technology
Scientific Title
Effects of visually induced self-motion illusion using a 360-degree camera in combination with VR technology
Scientific Title:Acronym
Effects of visually induced self-motion illusion using a 360-degree camera in combination with VR technology
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the possibility of treating stroke hemiplegia by inducing KINVIS using VR images captured with a 360-degree camera. Specific points of view are as follows. (1) Can KINVIS be induced in normal subjects by using VR images shot with a 360-degree camera? (2) Is there any difference in the effect of KINVIS between the conventional method and the method using VR images shot with a 360-degree camera in healthy subjects? (3) Does the same method induce KINVIS in stroke victims? (4) What are the characteristics of stroke victims who are prone to KINVIS?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Joint range of motion, muscle strength, gait speed, degree of body ownership (Likert scale), surface electromyography, FMA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: A 360-degree camera is used to capture the motion of one limb from a first-person perspective. The captured images are imported to a PC, and the left-right inverted images are presented on the HMD.
Interventions/Control_2
Control group: A still image of one limb is presented on the HMD.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with paralysis of the upper and lower extremities
Key exclusion criteria
Persons with dementia or severe higher brain dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MASAKAZU |
| Middle name | |
| Last name | MURAKAMI |
Organization
Japan Healthcare University
Division name
Faculty of Health Sciences Department of Rehabilitation
Zip code
0620053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
TEL
0113516100
mskz-murakami@jhu.ac.jp
Public contact
Name of contact person
| 1st name | MASAKAZU |
| Middle name | |
| Last name | MURAKAMI |
Organization
Japan Healthcare University
Division name
Faculty of Health Sciences Department of Rehabilitation
Zip code
0620053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
TEL
0113516100
Homepage URL
mskz-murakami@jhu.ac.jp
Sponsor or person
Institute
Japan Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Healthcare University
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
Tel
0113516100
mskz-murakami@jhu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059286
