UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031631 |
|---|---|
| Receipt number | 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 | 2021/04/05 15:09:29 |
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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
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
m.takashi0627@gmail.com
Sponsor or person
Institute
Nishikyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036099
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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