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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020114
Receipt No. R000023235
Scientific Title Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Date of disclosure of the study information 2015/12/22
Last modified on 2017/12/09

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Basic information
Public title Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Acronym Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Scientific Title Efficacy verification of unilateral spatial neglect treatment support system using a three-dimensional virtual reality space
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda University
Division name Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Zip code
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
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda University
Division name Graduate School of Creative Science and Engineering, Department of Modern Mechanical Engineering
Zip code
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)

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 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

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
2015 Year 09 Month 30 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023235

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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