UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026610 |
|---|---|
| Receipt number | R000030560 |
| Scientific Title | The study on the relationship between attention and awareness in the patients with unilateral spacial neglect |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/09/21 13:23:59 |
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Basic information
Public title
The study on the relationship between attention and awareness in the patients with unilateral spacial neglect
Acronym
The study on the relationship between attention and awareness in the patients with unilateral spacial neglect
Scientific Title
The study on the relationship between attention and awareness in the patients with unilateral spacial neglect
Scientific Title:Acronym
The study on the relationship between attention and awareness in the patients with unilateral spacial neglect
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relationship between attention and awareness in the patients with unilateral spacial neglect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioural Inattention Test
The Balloons Test
CBS
SF-8
Electroencephalograph(Event-related Potential)
Eye movement
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Electroencephalograph(EEG) and eye movement inspection(5times/4-5 months)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients with unilateral spatial neglect following on right hemisphere damage
Key exclusion criteria
Left handed
Dementia
Severe visual impairment
Aphasia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Graduate School of Medicine,Kyoto University
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Syogoin Kawahara-cho, Sakyo-ku, Kyoto-shi
TEL
075-751-3965
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Yokoyama |
Organization
Graduate School of Medicine,Kyoto University
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Syogoin Kawahara-cho, Sakyo-ku, Kyoto-shi
TEL
075-751-3965
Homepage URL
yokoyama.yoko.68w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Ethics Committe
Address
Yosidakonoe-cho, Sakyo-ku, Kyoto-shi
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2017 | Year | 04 | Month | 01 | 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
2
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030560
