UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045303 |
|---|---|
| Receipt number | R000051746 |
| Scientific Title | Verification of the effect of prism adaptation on healthy adults on sound source localization (multidirectional attention) in 360-degree horizontal space |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/08/14 11:05:22 |
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Basic information
Public title
Verification of the effect of prism adaptation on healthy adults on sound source localization (multidirectional attention) in 360-degree horizontal space
Acronym
Verification of the effect of prism adaptation on healthy adults on sound source localization (multidirectional attention) in 360-degree horizontal space
Scientific Title
Verification of the effect of prism adaptation on healthy adults on sound source localization (multidirectional attention) in 360-degree horizontal space
Scientific Title:Acronym
Verification of the effect of prism adaptation on healthy adults on sound source localization (multidirectional attention) in 360-degree horizontal space
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify whether prism adaptation affects sound source localization in a healthy person's 360-degree horizontal space
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sound source localization task using the speaker is measured three times in total for both the intervention group and the control group, before the prism adaptation intervention, immediately after the intervention, and 2 hours later.
Key secondary outcomes
The open loop pointing task and the line segment bisector task are measured three times in total for both the intervention group and the control group, before the prism adaptation intervention, immediately after the intervention, and 2 hours later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use PA glasses that are offset to the right by about 10 degrees.We will perform a task of quickly repeating the movement to reach the three targets, left and right and the center, placed in front of the subject in the chair sitting position 100 times. The implementation time is about 7 minutes.
Interventions/Control_2
Wearing eyeglasses that do not shift vision, the task of quickly reaching the three targets, left, right, and midline, placed in front of the subject in a chair sitting position, is repeated 100 times. The implementation time is about 7 minutes.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy adult
Key exclusion criteria
1) Persons with visual impairment, 2) Persons with hearing impairment, 3) Persons with a history of cerebrovascular accidents, 4) Persons with a history of significant locomotor disorders in the upper right limb
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto City, Japan
TEL
0962752111
matsuo-ta@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto City, Japan
TEL
0962752111
Homepage URL
matsuo-ta@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kumamoto Health Science University Life Science Ethics Review Board
Address
325 Izumi-machi, Kita-ku, Kumamoto City, Japan
Tel
096752111
kikaku@kumamoto-hsu.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
| 2021 | Year | 09 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051746
