UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033882
Receipt number R000038646
Scientific Title A study about the improvement in effect of movement by walking assist instruments (part 2)
Date of disclosure of the study information 2018/09/05
Last modified on 2020/02/26 09:54:49

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Basic information

Public title

A study about the improvement in effect of movement by walking assist instruments (part 2)

Acronym

A study about the improvement in effect of movement by walking assist instruments (part 2)

Scientific Title

A study about the improvement in effect of movement by walking assist instruments (part 2)

Scientific Title:Acronym

A study about the improvement in effect of movement by walking assist instruments (part 2)

Region

Japan


Condition

Condition

Pre-Frailty

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider the effect on gait by using walking assist instruments

Basic objectives2

Others

Basic objectives -Others

To compare the effect on gait by the presence or absence of walking assist instruments.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the interventional of walking assist instruments about physical activity, gait function, body composition, cognitive function.

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

Other

Interventions/Control_1

Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six weeks. -> Wash out for two weeks. -> Walking for 10 minutes for six weeks.

Interventions/Control_2

Walking for 10 minutes for six weeks. -> Wash out for two weeks. -> Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six weeks.

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

70 years-old <=

Age-upper limit

79 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects applied for one or two of the flail evaluation standards (all five questions) created by the National Center for Geriatrics and Gerontology.

Key exclusion criteria

-Subjects with difficult for walking.
-Subjects deemed inappropriate to participate in this study by the principle investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Motoki
Middle name
Last name Sudo

Organization

Kao Corporation

Division name

R&D -Development Research- Personal Health Care Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7486

Email

sudo.motoki@kao.com


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Ueda

Organization

Kao Corporation

Division name

R&D -Development Research- Personal Health Care Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7486

Homepage URL


Email

ueda.tomoya@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee, Kao COrporation

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.com


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

まちの健康研究所「あ・し・た」(千葉県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 05 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

30

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

Completed

Date of protocol fixation

2018 Year 07 Month 23 Day

Date of IRB

2018 Year 07 Month 23 Day

Anticipated trial start date

2018 Year 09 Month 06 Day

Last follow-up date

2019 Year 10 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 02 Month 26 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 24 Day

Last modified on

2020 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038646


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name