UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042526 |
|---|---|
| Receipt number | R000048338 |
| Scientific Title | Preliminary study of a visual attention task using virtual reality |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2025/02/28 17:23:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preliminary study of a visual attention task using virtual reality
Acronym
Preliminary study of a visual attention task using virtual reality
Scientific Title
Preliminary study of a visual attention task using virtual reality
Scientific Title:Acronym
Preliminary study of a visual attention task using virtual reality
Region
| Japan |
Condition
Condition
Healthy control
cognitive dysfunction
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To design a visual attention task which simulate shopping using virtual reality device and to examine the validity of the task.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the number of correct answers and the necessary time of the virtual reality task
Key secondary outcomes
Trail Making Test(TMT) PartA, PartB
Clinical Assessment for Attention(CAT) Tapping Span
Useful Field of View (Ufov)
Mini-Mental State Examination (MMSE)
Behavioural inattention test
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects do the virtual reality task and psychological tests.
Subjects answer self-report questionnaires about cybersickness, fatigue and presence after the virtual reality task.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Healthy people>
Those who had bought something at the supermarket
<People with cognitive dysfunction>
1. The doctor diagnosed as cognitive dysfunction with brain injuries
2. Hold a sitting position
3. Comprehensible a virtual reality task
Key exclusion criteria
<Healthy people>
1.Visual impairment
2.Mini Mental state Examination<=27
<People with cognitive dysfunction>
1. Visual impairment
2. Aphasia
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Haruko |
| Middle name | |
| Last name | Kashiwagi |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ot-dep@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Haruko |
| Middle name | |
| Last name | Kashiwagi |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ot-dep@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
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
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
37
Results
In this study, we created a visual search task in daily life situations using VR and verified the validity of the task using VR in healthy subjects. As a result, a correlation was found between the results of the VR task and the evaluation of visual attentional function, indicating that the task is related to visual attentional function. In addition, when we conducted a trial VR task for people with higher brain dysfunction, the exploration time of the VR task was longer than that of normal subjects.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
32 normal people (average age 40.59+-10.30, 15 male, 17 female)
5 people with high personal dysfunction (average age 58.40+-8.08 years old, 4 males, 1 female)
Participant flow
The intervention was conducted and analyzed for all 37 participants.
Adverse events
none
Outcome measures
1. Association between VR task and neuropsychological testing in healthy subjects
A positive correlation was found between the average search time of the VR task and TMT-B in healthy subjects (r=0.44,p<0.05). Regarding the search time for each product, the search time for 4 out of 12 products was correlated with TMT-B (p<0.05), and the search time for 5 out of 12 products was correlated with Ufov-test3 (p<0.05).
2. Preliminary study of VR tasks for people with higher brain dysfunction
The number of correct answers for 32 healthy subjects was 12+-0 questions, and the number of correct answers for 5 subjects with higher brain dysfunction was 11.60+-0.49 questions. The average search time for the normal subjects was 7.36+-2.44 seconds, while the average search time for the subjects with higher brain dysfunction was 14.32+-3.76 seconds.
Subjective evaluation of the VR task
Both normal subjects and those with higher brain dysfunction were able to perform the task without complaints of sickness or fatigue.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048338
