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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026548
Receipt No. R000030486
Scientific Title Risk of fall and its factors while waiting for a traffic light
Date of disclosure of the study information 2017/03/15
Last modified on 2019/02/27

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Basic information
Public title Risk of fall and its factors while waiting for a traffic light
Acronym Risk of fall and its factors while waiting for a traffic light
Scientific Title Risk of fall and its factors while waiting for a traffic light
Scientific Title:Acronym Risk of fall and its factors while waiting for a traffic light
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this research is to examine influence of sole contact on sloping surface and combined disturbance stimulus such as visual sense and auditory sense for standing postural control.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postural stability on standing position

Key secondary outcomes Postural sway
Stability limit

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Evaluation of ordinary standing position
1 time 2 min. period 1 day
Evaluation of standing position under combined disturbance stimulus 1 time 2 min. period 1 day
Evaluation of standing position on sloping surface
1 time 2 min. period 1 day
Evaluation of standing position under combined disturbance stimulus on sloping surface
1 time 2 min. period 1 day
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

Not applicable
Gender Female
Key inclusion criteria Healthy adult
Key exclusion criteria Cognitive disorders
Movement disorders
Sensory disorder
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Tanaka
Organization Hokkaido University of Science
Division name Dept. of Physical Therapy Faculty of Health Sciences
Zip code
Address 7-15-4-1 Maeda, Teine, Sapporo, Hokkaido
TEL 011-688-2410
Email tanaka-y@hus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Tanaka
Organization Hokkaido University of Science
Division name Dept. of Physical Therapy Faculty of Health Sciences
Zip code
Address 7-15-4-1 Maeda, Teine, Sapporo, Hokkaido
TEL 011-688-2410
Homepage URL
Email tanaka-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
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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
At the time of signal waiting, at least the inclination of the sidewalk is related as a factor which increases the risk of falling.The relation with the visual information and the noise of the cars going and going was not clear.
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
2017 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 21 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030486

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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