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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025531
Receipt No. R000029386
Scientific Title Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Date of disclosure of the study information 2017/01/05
Last modified on 2017/01/05

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Basic information
Public title Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Acronym Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Scientific Title Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Scientific Title:Acronym Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Region
Japan

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

Objectives
Narrative objectives1 In the past, balance evaluation equipment was focused on static evaluation, but recently dynamic evaluation equipment has been developed.However, there is no data that supports the relationship between the behavior being evaluated by these devices and falling.In 2002 the Four Square Step Test was announced. The relationship between FSST results and falls was demonstrated.The original FSST is just a total time measurement.However, we have developed a device that can evaluate moving motion by decomposing it into right / left / front / back motion. We developed a device (device capable of detecting weak moving direction ) that can detect the direction which took time by moving.Healthy elderly perform exercises specialized in individual weak movement directions.As a result, we will consider reducing the fall frequency , shortening the travel time to individual weak moving directions and influence of cognitive function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Moving time to individual weak moving direction
Key secondary outcomes Fall frequency
Lower limb muscle strength
Single leg upright time
Questionnaire of HDS-R

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 Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Using the developed equipment, healthy elderly do specialized training in a disadvantage direction.Training is 20 times in total, 10 minutes a week, 2-3 times a week.Movement training uses subtraction. The answer of subtraction is set to be 1 to 8. Numbers 1 to 8 are displayed on the monitor. The examinee moves in the direction of the answer of the same subtraction as the displayed number.
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 65 years and over
85 years old or younger
Participants can exercise.
Participants can understand the research contents.
It is possible to acquire consent from the principal.
Key exclusion criteria Under the age of 64
There are exercisers, cerebrovascular, cardiovascular and respiratory diseases that interfere with exercise intervention.
Participants can not understand the research contents.
It is impossible to acquire consent from the principal.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Nagano
Organization Kochi Medical School Hospital
Division name Department of Rehabilitation Center
Zip code
Address Nankoku, Kochi 783-8505, Japan
TEL 0888802490
Email yasumati@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Nagano
Organization Kochi Medical School Hospital
Division name Department of Rehabilitation Center
Zip code
Address Nankoku, Kochi 783-8505, Japan
TEL 0888802490
Homepage URL
Email yasumati@kochi-u.ac.jp

Sponsor
Institute Department of Rehabilitation Center,Kochi Medical School Hospital
Institute
Department

Funding Source
Organization KYUSHU UNIVERSITY
Center for clinical and Translational Resesrch(CCTR)
Organization
Division
Category of Funding Organization Non profit foundation
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 01 Month 05 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029386

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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