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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033601
Receipt No. R000038318
Official scientific title of the study Field survey aimed at preventing falls of elderly residents living in the area
Date of disclosure of the study information 2018/08/02
Last modified on 2018/08/02

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Basic information
Official scientific title of the study Field survey aimed at preventing falls of elderly residents living in the area
Title of the study (Brief title) Survey for fall prevention
Region
Japan

Condition
Condition Healthy elderly people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will quantitatively verify the influence of socks for plantar sensory stimulation on the static and dynamic balance function for elderly residents living in the area. As a control condition for socks for plantar sensory stimulation, measurement is carried out under ordinary socks and bare feet without small protrusions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed Up &Go test
Key secondary outcomes Center of gravity fluctuation (total trajectory length, effective value area) at the time of open-eye / closed-eyed standing, temporal and spatial parameters at 10 m walking, two point identification distances at the sole

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Plantar sensory stimulation with small spike-socks/Barefoot/Normal socks
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 Teiji Kimura
Organization Shinshu University
Division name Department of Physical Therapy, School of Health sciences,
Address Nagano Prefecture Matsumoto-shi Asahi3-1-1
TEL 0263-37-2407
Email tkimura@shinshu-u.ac.jp

Public contact
Name of contact person Takahiro Baba
Organization Kakeyu-Misayama Rehabilitation Center Geriatric Health Services Facility Izumino
Division name Department of medical technology
Address Nagano Prefecture ueda-shi koizumi72-1
TEL 0268-26-6600
Homepage URL
Email 13mk005f@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Name of secondary funder(s) Taiko Corporation

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 03 Day
Anticipated trial start date
2018 Year 08 Month 02 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
2018 Year 08 Month 02 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038318

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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