UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026548
Receipt number 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 14:10:02

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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 or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



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

Value
https://center6.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