UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Title of the study (Brief title)	Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Region	Japan

Condition
Condition	Unilateral spatial neglect in stroke patients.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Integrated improvement of unilateral spatial neglect in far and near space.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Line cancellation, Line bisection, star cancellation and letter cancellation task. Time of assessment:immediately before the intervention and immediately after the intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients were attached a Head-mounted display (HMD) and presented three-dimensional Virtual reality space where multiple objects were installed. First, they answer aloud the objects' name of far space in three-dimensional Virtual reality space with HMD. Second, they touch the objects of near space with one hand that is synchronized their hand of real in three-dimensional Virtual reality space with HMD. At this time, they are promoted attentional disengagement from the ipsilesional stimuli by blocking visual stimuli to direct attention and attentional movement from the ipsilesional to the contralesional side by expanding the visible area to contralesional side. They took about 6 minutes.
Interventions/Control_2	Patients were seated at a desk. They conducted visual scanning training on the desk. The task of the patients is to answer the objects' name that is pointed by therapist. The objects were installed on the desk. They took about 6 minutes.
Interventions/Control_3	Patients were seated at a desk. They conducted visual scanning training on the screen. The screen is installed in front of the patient. The task of the patients is to answer the objects' name that is pointed by therapist. The objects were installed on the screen. They took about 6 minutes.
Interventions/Control_4	Patients were attached a Head-mounted display (HMD) and presented three-dimensional Virtual reality space where multiple objects were installed. They answer aloud the objects' name of far space in three-dimensional Virtual reality space with HMD. At this time patients attention is inducted to neglect side of a object. They took about 13 minutes.
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)Scoring less than the cut off value in the line cancellation task. (2)No severe cognitive impairment (Mini-Mental State Examination, MMSE >15).
Key exclusion criteria	(1)unable to understand the task because of aphasia or other cognitive impairment. (2)unable to sit on a wheelchair. (3)Unable to recognize objects on a screen due to severely damaged eyesight. (4)unable to reach with the upper limb extremity because of restricted range of motion. (5)Inability to give informed consent form.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroyasu Iwata
Organization	Waseda University
Division name	Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Address	Waseda University, Green Computing System Research Organization 40-603, Waseda-cho 27, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	Hiroyasu Iwata
Organization	Waseda University
Division name	Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Address	Waseda University, Green Computing System Research Organization 40-603, Waseda-cho 27, Shinjuku-ku,
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	亀田総合病院（千葉県），横浜新緑総合病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 12 Month 16 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

Management information
Registered date	2015 Year 12 Month 08 Day
Last modified on	2017 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023235