UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017588
Receipt number R000020362
Scientific Title The effect of foot bath on cutaneous warm and cool sensation thresholds
Date of disclosure of the study information 2016/05/15
Last modified on 2015/05/15 15:24:47

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Basic information

Public title

The effect of foot bath on cutaneous warm and cool sensation thresholds

Acronym

The effect of foot bath on cutaneous warm and cool sensation thresholds

Scientific Title

The effect of foot bath on cutaneous warm and cool sensation thresholds

Scientific Title:Acronym

The effect of foot bath on cutaneous warm and cool sensation thresholds

Region

Japan


Condition

Condition

hypertension

Classification by specialty

Medicine in general Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the effect of foot bath on cutaneous warm and cool sensation thresholds

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cutaneous warm and cool sensation thresholds

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

foot bath

Interventions/Control_2

control

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

over 65 years old

Key exclusion criteria

unstable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Chisyaki

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code


Address

Maidashi Higashi-ku Fukuoka Japan

TEL

092-642-6713

Email

chishaki@hs.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuko Hashiguchi

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code


Address

Maidashi Higashi-ku Fukuoka Japan

TEL

092-642-6714

Homepage URL


Email

n-hashi@hs.med.kyushu-u.ac.jp


Sponsor or person

Institute

Nobuko Hashiguchi

Institute

Department

Personal name



Funding Source

Organization

Grants in aid for Scientific Research

Organization

Division

Category of Funding Organization

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

2016 Year 05 Month 15 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

Enrolling by invitation

Date of protocol fixation

2014 Year 12 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 15 Day

Last modified on

2015 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020362


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name