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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028356
Receipt No. R000032454
Scientific Title Clicical evaluation of VR tracking system aimed at improving ignorance in real life of USN patients.
Date of disclosure of the study information 2017/08/31
Last modified on 2017/07/24

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Basic information
Public title Clicical evaluation of VR tracking system aimed at improving ignorance in real life of USN patients.
Acronym Clicical evaluation of VR tracking system aimed at improving ignorance in real life of USN patients.
Scientific Title Clicical evaluation of VR tracking system aimed at improving ignorance in real life of USN patients.
Scientific Title:Acronym Clicical evaluation of VR tracking system aimed at improving ignorance in real life of USN patients.
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 Improvement of ignoring symptoms caused in an environment close to real life.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients were attached a Head-mounted display(HMD) and presented presented three-dimensional Virtual reality space where multiple objects were installed including a traffic light. When the blue light of the traffic light glow patients put the joystick forward.
They took about 20 minutes.
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)Scoring less than the cut off value in BIT.
(2)Able to write lines on the lines that are printed on the line cancellation task.
(3)Able to check lines on the line cancellation task
(4)Without half blindness
Key exclusion criteria (1) uncontrolled heart failure
(2) acute myocardial infarction
(3) active myocarditis, or pericarditis
(4) unstable angina
(5) acute advancing embolism, or pulmonary embolism
(6) acute infection
(7) thrombophlebitis
(8) ventricular tachycardia or refractory ventricular arrhythmia
(9) Severe ventricular outflow tract obstruction
(10) uncontrolled arterial hypertension, or pulmonary hypertension
(11) If you are a subject of other intervention studies at the same time (verbally verified to the physiotherapist in charge)
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
2017 Year 08 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
2017 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 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
2017 Year 07 Month 24 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032454

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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