UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of exercise and cognitive function by dynamic evaluation equipment for fall prediction
Title of the study (Brief title)	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	Yasunori Nagano
Organization	Kochi Medical School Hospital
Division name	Department of Rehabilitation Center
Address	Nankoku, Kochi 783-8505, Japan
TEL	0888802490
Email	yasumati@kochi-u.ac.jp

Public contact
Name of contact person	Yasunori Nagano
Organization	Kochi Medical School Hospital
Division name	Department of Rehabilitation Center
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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