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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032083
Receipt No. R000036600
Scientific Title The effect of balance control on plantar vibration stimuli for elderly
Date of disclosure of the study information 2018/04/03
Last modified on 2019/03/19

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Basic information
Public title The effect of balance control on plantar vibration stimuli for elderly
Acronym Plantar vibration stimuli for elderly
Scientific Title The effect of balance control on plantar vibration stimuli for elderly
Scientific Title:Acronym Plantar vibration stimuli for elderly
Region
Japan

Condition
Condition Elderly
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The assesment effects of plantar vibration stimuli bout on clinical performance and body balance in the subject
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The center of pressure of the total trajectory length
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 2-min plantar vibration stimuli
Interventions/Control_2 2-min sham vibration stimuli
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The elderly peopleable to stand independently for 90 s and able to walk 10 m
Key exclusion criteria cardiovascular, respiratory, abdominal, urinary, gynaecological, neurological,
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke oku
Organization Shijonawate Gakuen University
Division name Faculty of Rehabilitation
Zip code
Address Hojo 5-11-10, Daitou City, Osaka
TEL 81-728-635-043
Email k-oku@un.shijonawate-gakuen.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke oku
Organization Shijonawate Gakuen University
Division name Faculty of Rehabilitation
Zip code
Address Hojo 5-11-10, Daitou City, Osaka
TEL 81-728-635-043
Homepage URL
Email k-oku@un.shijonawate-gakuen.ac.jp

Sponsor
Institute Nara Medical University Graduate School
Institute
Department

Funding Source
Organization Nara Medical University Graduate School
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 Month 03 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2016 Year 11 Month 14 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2017 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 03 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036600

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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