UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034716 |
|---|---|
| Receipt number | R000039512 |
| Scientific Title | Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2018/10/31 15:31:00 |
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Basic information
Public title
Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Acronym
Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Scientific Title
Development of evaluation system using immersive virtual reality in stroke patients with unilateral spatial neglect
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda university
Division name
Department of modern mechanical engineering
Zip code
Address
Bld.No40-#603, Waseda University Green Computing System Research Organization, 27, Waseda-cho, Sinjyuku-ku, Tokyo, 162-0042, Japan
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
Department of modern mechanical engineering
Zip code
Address
#603, Waseda University Green Computing System Research Organization, 27, Waseda-cho, Sinjyuku-
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda university
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
| 2018 | Year | 05 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039512
