UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037638 |
|---|---|
| Receipt number | R000042899 |
| Scientific Title | Immediate effect of search task on center of gravity in the field of deviation by immersive Virtual Reality |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2022/02/21 07:43:30 |
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Basic information
Public title
Immediate effect of search task on center of gravity in the field of deviation by immersive Virtual Reality
Acronym
Immediate effect of search task on center of gravity in the field of deviation by immersive Virtual Reality
Scientific Title
Immediate effect of search task on center of gravity in the field of deviation by immersive Virtual Reality
Scientific Title:Acronym
Immediate effect of search task on center of gravity in the field of deviation by immersive Virtual Reality
Region
| Japan |
Condition
Condition
Unilateral spatial neglect
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether a search task using an immersive Virtual Reality device affects the mid-center position.
The field of view during the search task is deviated 10
degree to the right.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of center gravity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Subjects wear an immersive head mount display (HMD) to perform search tasks.
In the intervention group, the monitor in the HMD is shifted 10 degree to the left.
The number of stimulations is 40.
Subjects perform one time , and then evaluate immediate
effect.
Interventions/Control_2
Subjects wear an immersive head mount display (HMD) to perform search tasks.
In the normal group, the monitor in the HMD is not shifted .
The number of stimulations is 40.
Subjects perform one time , and then evaluate immediate
effect.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were healthy young people (20 to 39) years old) and elderly people (60 to 79) years old) in the intervention group and the control group, respectively.
Key exclusion criteria
There is significant visual acuity or visual field impairment or abnormalities in inner ear disorder or abnormal equilibrium.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Mishuku Hospital
Division name
Department of rehabilitation
Zip code
1530051
Address
5-33-12, kamimeguro, meguro-ward,Tokyo
TEL
0337115771
k.motomura128@gmail.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Mishuku Hospital
Division name
Department of rehabilitation
Zip code
1530051
Address
5-33-12, kamimeguro, meguro-ward,Tokyo
TEL
0337115771
Homepage URL
k.motomura128@gmail.com
Sponsor or person
Institute
Mishuku Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Mishuku Hospital
Address
5-33-12, kamimeguro, meguro-ward,Tokyo
Tel
0337115771
k.motomura128@gmail.com
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 | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
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
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042899
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
