UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033601 |
|---|---|
| Receipt number | R000038318 |
| Scientific Title | Field survey for fall prevention in community-dwelling older people |
| Date of disclosure of the study information | 2018/08/02 |
| Last modified on | 2020/11/06 13:43:03 |
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Basic information
Public title
Field survey for fall prevention in community-dwelling older people
Acronym
Survey for fall prevention
Scientific Title
Field survey for fall prevention in community-dwelling older people
Scientific Title:Acronym
Survey for fall prevention
Region
| Japan |
Condition
Condition
Community-dwelling older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of Study 1 is to quantitatively measure the walking function of community-dwelling elderly people, including those who have fallen and those who have not fallen, using a simple, highly accurate, compact and lightweight walking function measuring device, and to measure the fall of the elderly. We will verify the validity and reliability of the temporal and spatial parameters of walking for risk screening as cut-off values. If it is possible to show a cut-off value that distinguishes people with a high risk of falls among the elderly living in the area from daily walking data, in order to promote fall prevention in Japan's super-aging society in the future. It is expected to help determine the need for intervention.
The purpose of Study 2 is to quantitatively verify the effect of socks for plantar sensory stimulation on static and dynamic balance functions in community-dwelling elderly people. If it can be confirmed in Study 2 that the balance function is improved by wearing socks for stimulating the sole sensation of the elderly living in the area, it will be worn by the elderly at home and the elderly living in the facility on a daily basis. It is expected that this will lead to the development of socks for stimulating the sole sensation that can continuously promote the improvement of the balance function in both indoor and outdoor situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1: temporo-spatial characteristics of gait
Study 2: Timed Up &Go test
Key secondary outcomes
Study 1: history of falls during the past year
Study 2: center of gravity fluctuation (total trajectory length, effective value area) at the time of open-eye / closed-eyed standing, two point identification distances at the sole
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly residents living in areas where daily living movements are independent.Person who got written informed consent based on free will of patient after receiving sufficient explanation for participation in this research.
Key exclusion criteria
person who can not understand the contents of the task.Persons who have neurological disorders that exhibit sensory disturbances or balance disorders in the lower limbs.Persons who have pain at the sole.Person who is using cane.person with a history of operation in the leg joints.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Teiji |
| Middle name | |
| Last name | Kimura |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health sciences,
Zip code
390-8621
Address
Nagano Prefecture Matsumoto-shi Asahi3-1-1
TEL
0263-37-2407
tkimura@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Baba |
Organization
Kakeyu-Misayama Rehabilitation Center Geriatric Health Services Facility Izumino
Division name
Department of medical technology
Zip code
386-8688
Address
Nagano Prefecture ueda-shi koizumi72-1
TEL
0268-26-6600
Homepage URL
13mk005f@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Physical Education and Medicine Research Foundation
Taiko corporation(study 2 only)
Name of secondary funder(s)
Taiko corporation(study 2 only)
IRB Contact (For public release)
Organization
The approval of the Shinshu University School of Medicine Medical Ethics Committee
Address
Nagano Prefecture Matsumoto-shi Asahi3-1-1
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
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
| 2018 | Year | 08 | Month | 02 | 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
50
Results
Study1:In 34 people in the non-faller group and 16 people in the faller group,velocity and left and right heel strike angles were significantly different.
Study2:Based on the data of 39 subjects (9 males and 30 females), a significant difference was observed in the execution time of TUG under the three conditions of socks for plantar sensory stimulation, normal socks, and barefoot.
Results date posted
| 2020 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
From May 1, 2018 to January 31, 2020, we recruited people who are using long-term care prevention services and conducted a cross-sectional study.
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038318
