UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041859 |
|---|---|
| Receipt number | R000047786 |
| Scientific Title | Effect of visual search training on attention function using immersive virtual reality for stroke patients: comparison between immersive virtual reality and visual exploration training on paper |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/22 12:37:58 |
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Basic information
Public title
Effect of visual search training on attention function using immersive virtual reality for stroke patients: comparison between immersive virtual reality and visual exploration training on paper
Acronym
Effects of visual search training using immersive virtual reality on attentional function in stroke patients
Scientific Title
Effect of visual search training on attention function using immersive virtual reality for stroke patients: comparison between immersive virtual reality and visual exploration training on paper
Scientific Title:Acronym
Effects of visual search training using immersive virtual reality on attentional function in stroke patients
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether visual search tasks in three-dimensional space using immersive virtual reality can improve attentional functions and be generalized to daily life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One month after the onset of cerebrovascular disease, the TMT, an assessment of attentional function, is used to assess the patient
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Immersive virtual reality visual exploration tasks for 20 minutes per day for a total of 14 days.
Interventions/Control_2
Visual exploration tasks with desk-based tasks for 20 minutes per day for a total of 14 days
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a first stroke one month after the onset
Key exclusion criteria
A person who has difficulty in directing and understanding
Persons with dizziness or nausea/VR sickness
Those who have difficulty with desk inspection
Persons with Unilateral Spatial Neglect
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Sonodakai Rehabilitation Hospital
Division name
Rehabilitation Department
Zip code
3400824
Address
103 Rising Place, 354-1 Gake, Yashio City, Saitama Prefecture
TEL
09054290370
hoa12018@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Sonodakai Rehabilitation Hospital
Division name
Rehabilitation Department
Zip code
3400824
Address
103 Rising Place, 354-1 Gake, Yashio City, Saitama Prefecture
TEL
09054290370
Homepage URL
hoa12018@nuhw.ac.jp
Sponsor or person
Institute
Sonodakai Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Science and Technology, Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sonodakai Rehabilitation Hospital
Address
5-9-11 Yanaka, Adachi-ku, Tokyo
Tel
0336051108
hoa12018@nuhw.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
| 2020 | 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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 09 | Month | 22 | Day |
Last modified on
| 2020 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047786
