UMIN-CTR Clinical Trial

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	2016 Year 07 Month 01 Day
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	2021 Year 04 Month 05 Day

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