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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031631
Receipt No. R000036099
Scientific Title Development and effectiveness verification of training using sound direction sense(sound Localization)for left unilateral spatial neglect
Date of disclosure of the study information 2018/03/07
Last modified on 2018/08/17

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Basic information
Public title Development and effectiveness verification of training using sound direction sense(sound Localization)for left unilateral spatial neglect
Acronym Development and effectiveness verification of training using sound direction sense(sound Localization)for left unilateral spatial neglect
Scientific Title Development and effectiveness verification of training using sound direction sense(sound Localization)for left unilateral spatial neglect
Scientific Title:Acronym Development and effectiveness verification of training using sound direction sense(sound Localization)for left unilateral spatial neglect
Region
Japan

Condition
Condition patients with stroke, traumatic encephalopathy
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the sound localization on unilateral spatial neglect after stroke and traumatic encephalopathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioural inattention test-conventional subtest
Time of assessment:baseline,post,follow up(2w,4w)
Key secondary outcomes Sound localization task
Catherine Bergego Scale
Time of assessment:baseline,post,follow up(2w,4w)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 The Sound Localization task on unilateral spatial neglect for two weeks.(15minute/1day)
Interventions/Control_2 Control group does not implement sound localization task.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with left unilateral spatial neglect by stroke and traumatic encephalopathy(Determined by the BIT and CBS)
(1)Sound source localization task can be accomplished
(2)patients without hearing loss
(3)patients without marked cervical movement limitations that might hinder measurement tasks
(4)patients presenting with supratentorial lesion(s)
(5)patients without cortical deafness
(6)right hemisphere damage(stroke,Brain tumor)
(7)Consent to participate in the study
Key exclusion criteria (1)patients' refusal for participation.
(2)patients with extremely decreased eyesight
(3)aphasia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Matsuo
Organization Nishikyushu University
Division name Faculty of Rehabilitation Sciences
Zip code
Address Ozaki 4490--9, Kanzaki, Kanzaki-city, Saga, Japan
TEL 0952-37-9326
Email m.takashi0627@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Matsuo
Organization Nishikyushu University
Division name Faculty of Rehabilitation Sciences
Zip code
Address Ozaki 4490--9, Kanzaki, Kanzaki-city, Saga, Japan
TEL 0952-37-9326
Homepage URL
Email m.takashi0627@gmail.com

Sponsor
Institute Nishikyushu University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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 白石共立病院(佐賀県)、ひらまつ病院(佐賀県)、桜十字福岡病院(福岡県)、三原台病院(長崎県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 07 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 Completed
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 10 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 01 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 07 Day
Last modified on
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036099

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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