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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041859
Receipt No. 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

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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
Email 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
Email hoa12018@nuhw.ac.jp

Sponsor
Institute Sonodakai Rehabilitation Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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