UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Title of the study (Brief title)	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	Hiroyasu Iwata
Organization	Waseda university
Division name	Department of modern mechanical engineering
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	Hiroyasu Iwata
Organization	Waseda university
Division name	Department of modern mechanical engineering
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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