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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034716
Receipt No. R000039512
Scientific Title Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/31

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Basic information
Public title Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Acronym Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Scientific Title Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Scientific Title:Acronym Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Region
Japan

Condition
Condition Patients with unilateral spatial neglect
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure neglect area of patients in three-dimensional space. And, to implement the appropriate rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioral inattention test
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Stroke patients with unilateral spatial neglect in the middle.
2.Those who can do line bisection test without help.
3.Those who don't have half blind.
Key exclusion criteria 1.Heart failure which is not controlled
2.Acute myocardial infarction
3.Activities myocarditis or pericarditis
4.Unstable angina pectoris
5.Acute embolic shower or pulmonary embolism
6.Acute infection
7.Thrombophlebitis
8.Ventricular tachycardia or intractable ventricular arrhythmia
9.Severe ventricular outflow tract obstruction
10.Uncontrolled arterial hypertension or pulmonary hypertension
11.The case of the patient who is a target of other intervention study at the same time
(Exception is judged by doctor in charge)
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Department of modern mechanical engineering
Zip code
Address Bld.No40-#603, Waseda University Green Computing System Research Organization, 27, Waseda-cho, Sinjyuku-ku, Tokyo, 162-0042, Japan
TEL 03-3203-4427
Email jubi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Department of modern mechanical engineering
Zip code
Address #603, Waseda University Green Computing System Research Organization, 27, Waseda-cho, Sinjyuku-
TEL 03-3203-4427
Homepage URL
Email jubi@waseda.jp

Sponsor
Institute Waseda university
Institute
Department

Funding Source
Organization Waseda university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 10 Month 31 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
2018 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We observe ignore symptoms of unilateral spatial neglect.

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039512

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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