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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031725
Receipt No. R000036119
Scientific Title Effect of prism adaptation on sound localization abilities in left unilateral spatial neglect
Date of disclosure of the study information 2018/03/14
Last modified on 2018/08/18

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Basic information
Public title Effect of prism adaptation on sound localization abilities in left unilateral spatial neglect
Acronym Effect of prism adaptation on sound localization abilities in left unilateral spatial neglect
Scientific Title Effect of prism adaptation on sound localization abilities in left unilateral spatial neglect
Scientific Title:Acronym Effect of prism adaptation on sound localization abilities in left unilateral spatial neglect
Region
Japan

Condition
Condition stroke
brain tumor
traumatic encephalopathy
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to examine the effects of prism adaptation (PA) on sound localization abilities in patients presenting with left unilateral spatial neglect
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes simple sound localization task
Time of assessment : before intervention,just after intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 prism adaptation in addition to usual rehabilitation program
Intervention time is prism adaptation of one session.(approximately 8 minutes)
Interventions/Control_2 Usual rehabilitation program alone
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 (1)patients without severe dementia who were capable of understanding and completing the sound localization tasks
(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)patients with left-USN(Determined by the BIT and CBS)
(8)Consent to participate in the study
Key exclusion criteria (1)patients' refusal for participation.
(2)patients with extremely decreased eyesight
(3)unable to reach with the right upper extremity
(4)aphasia
Target sample size 30

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 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
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)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 09 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036119

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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