UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045012 |
|---|---|
| Receipt number | R000051419 |
| Scientific Title | Characteristics in a visual attention task using virtual reality for people with cognitive dysfunction. |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2025/02/28 17:30:45 |
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Basic information
Public title
Characteristics in a visual attention task using virtual reality for people with cognitive dysfunction.
Acronym
Characteristics in a visual attention task using virtual reality for people with cognitive dysfunction.
Scientific Title
Characteristics in a visual attention task using virtual reality for people with cognitive dysfunction.
Scientific Title:Acronym
Characteristics in a visual attention task using virtual reality for people with cognitive dysfunction.
Region
| Japan |
Condition
Condition
cognitive dysfunction
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between a visual attention task which simulate shopping using virtual reality device and neuropsychological tests.
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
Mini-Mental State Examination (MMSE)
Trail Making Test(TMT)PartA, PartB
Clinical Assessment for Attention(CAT)Tapping Span
Useful Field of View(UFOV)
Behavioural inattention test-Picture Scanning
Behavioural Assessment of the Dysexecutive Syndrome(BADS)-Zoo map
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 neuropsychological tests.
Subjects answer self-report questionnaires about cybersickness, fatigue and presence and Simulator Sickness Questionnaire(SSQ) 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
1. Patients with cognitive dysfunctions by brain injury.
2. Hold a sitting position.
3. Comprehensible a virtual reality task.
Key exclusion criteria
1. Visual impairment
2. Dementia
3. Difficulty in cervical movement due to Orthopedic disease
4. Severe aphasia
Target sample size
30
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
| 2021 | Year | 07 | Month | 30 | 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
17
Results
In this study, we created a visual search task in a shopping situation using VR, and examined the relationship between the VR task and neuropsychological tests in subjects with higher brain dysfunction. The results showed that there was a correlation with the visual attention test. The subjects with higher-order brain dysfunction took longer time to search for the VR task than 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
Seventeen patients with higher brain dysfunction, mean age 47.9+-6.8 (35-58) years.
Participant flow
All 17 subjects were subjected to the intervention and included in the analysis.
Adverse events
none
Outcome measures
1. Comparison of VR tasks between persons with higher brain dysfunction and normal subjects
Of the 12 questions of the VR task, 8 questions were longer in the patients with higher-order brain dysfunction than in the normal subjects (p<0.05).
2. Relationship between the VR task and neuropsychological testing in persons with higher brain dysfunction
Among neuropsychological tests, the TMT-A, TMT-B, and UFOV test2 and UFOV test3 showed a significant positive correlation with exploration time in VR tasks (p<0.05). Other neuropsychological tests such as CAT Tapping Span, BIT photographic task, and BADS zoo map test showed no correlation with the exploration time of the VR task.
3. Subjective evaluation of the VR task
In the subjective evaluation of the VR task, the "Was it difficult to see?" question showed that normal subjects had more difficulty seeing than those with higher brain dysfunction (p<0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 30 | 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=R000051419
