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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026610
Receipt No. 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 2019/05/29

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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
Email 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
Email yokoyama.yoko.68w@st.kyoto-u.ac.jp

Sponsor
Institute Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030560

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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