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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027415
Receipt No. R000031417
Scientific Title Change of static standing and forward walking without visual information as changed sound conditions
Date of disclosure of the study information 2017/05/19
Last modified on 2019/11/26

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Basic information
Public title Change of static standing and forward walking without visual information as changed sound conditions
Acronym Relationship between sound conditions and balance ability
Scientific Title Change of static standing and forward walking without visual information as changed sound conditions
Scientific Title:Acronym Relationship between sound conditions and balance ability
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of sounds on balance ability
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postural sway during static standing
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Experiments performs about one hour
Eye closed
Sound effects at 70dB
Interventions/Control_2
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
35 years-old >=
Gender Male and Female
Key inclusion criteria No disability of auditory sense
No disability of musculoskeletal system
Key exclusion criteria Individual with disability of auditory sense
Individual with disability of musculoskeletal system
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoichiro
Middle name
Last name Sato
Organization Hokkaido University of Science
Division name Department of Physical Therapy
Zip code 006-8585
Address 7-15-4-1 Maeda, Teine, Sapporo Japan
TEL 0116887192
Email sato-y@hus.ac.jp

Public contact
Name of contact person
1st name Yoichiro
Middle name
Last name Sato
Organization Hokkaido University of Science
Division name Department of Physical Therapy
Zip code 006-8585
Address 7-15-4-1 Maeda, Teine, Sapporo Japan
TEL 0116887192
Homepage URL
Email sato-y@hus.ac.jp

Sponsor
Institute Hokkaido University of Science
Institute
Department

Funding Source
Organization Hokkaido University of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University of Science
Address 15-4-1, Maeda 7-jo, Teine
Tel 011-688-2241
Email kenkyu@hus.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
2017 Year 05 Month 19 Day

Related information
URL releasing protocol no cite
Publication of results Unpublished

Result
URL related to results and publications no cite
Number of participants that the trial has enrolled 20
Results
The body sway during quiet standing was larger in condition that eyes closed and hearing tone from both sides than no tone condition.
Results date posted
2019 Year 11 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Health young adults
Participant flow
Public offering
Adverse events
No
Outcome measures
Body sway
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
2017 Year 01 Month 30 Day
Anticipated trial start date
2017 Year 05 Month 20 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2019 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031417

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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