UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025251 |
|---|---|
| Receipt number | R000029044 |
| Scientific Title | Usefulness of dynamic evaluation equipment for fall prediction |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2016/12/13 16:28:51 |
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Basic information
Public title
Usefulness of dynamic evaluation equipment for fall prediction
Acronym
Usefulness of dynamic evaluation equipment for fall prediction
Scientific Title
Usefulness of dynamic evaluation equipment for fall prediction
Scientific Title:Acronym
Usefulness of 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 and shortening the travel time to individual weak moving directions.
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 evaluation (Locomo 25)
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 5 minutes per minute, twice weekly, 3 months.
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 understand the research content.
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 who can not understand the research contents.
It is impossible to acquire consent from the principal.
Target sample size
50
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
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
yasumati@kochi-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Center,Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION SCIENCE
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
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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 13 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2016 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029044
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
