UMIN-CTR Clinical Trial

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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