UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032083 |
|---|---|
| Receipt number | 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 15:52:29 |
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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
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
k-oku@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Nara Medical University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036600
