UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022524
Receipt number R000025962
Scientific Title Evaluation measurement of the influence on the gait posture of the elderly people of newly developed products
Date of disclosure of the study information 2020/03/31
Last modified on 2016/05/30 13:58:56

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Basic information

Public title

Evaluation measurement of the influence on the gait posture of the elderly people of newly developed products

Acronym

Evaluation measurement of the influence on the gait posture of the elderly people of newly developed products

Scientific Title

Evaluation measurement of the influence on the gait posture of the elderly people of newly developed products

Scientific Title:Acronym

Evaluation measurement of the influence on the gait posture of the elderly people of newly developed products

Region

Japan


Condition

Condition

Locomotive syndrome

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation measurement of the influence which I have on the gait posture of the elderly people of newly developed products.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

A gait posture when use newly developed product.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

0cm,1cm,3cm
0cm,3cm,1cm
1cm,3cm,0cm
1cm,0cm,3cm
3cm,1cm,0cm
3cm,0cm,1cm

Interventions/Control_2


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

60 years-old <=

Age-upper limit

70 years-old >

Gender

Female

Key inclusion criteria

Healthy female age is in the sixties

Key exclusion criteria

Who have the experience which experiencethe big injury

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Inoue Jun

Organization

Tokyo Denki University

Division name

Department of Robotics and Mechatoronics

Zip code


Address

5 senju-asahi-cho adachiku Tokyo

TEL

03-5284-5613

Email

inoue.jun@fr.dendai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Inoue Jun

Organization

Tokyo Denki University

Division name

Department of Robotics and Mechatoronics

Zip code


Address

5 senju-asahi-cho adachiku Tokyo

TEL

03-5284-5613

Homepage URL


Email

inoue.jun@fr.dendai.ac.jp


Sponsor or person

Institute

Tokyo Denki University

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


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

2020 Year 03 Month 31 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

No longer recruiting

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 11 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

2016 Year 05 Month 30 Day

Last modified on

2016 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name