UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020114 |
|---|---|
| Receipt number | 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 10:09:01 |
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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
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
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023235
