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

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 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


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

Value
https://center6.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