UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044709
Receipt number R000051050
Scientific Title Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls
Date of disclosure of the study information 2021/06/29
Last modified on 2021/06/29 21:43:55

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Basic information

Public title

Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls

Acronym

Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls

Scientific Title

Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls

Scientific Title:Acronym

Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls

Region

Japan


Condition

Condition

Health adults and elderly people requiring support

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development and validation of a new screening test of measure lower extremity agility using a single step forward to attempt to regain standing balance to avoid falls

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the time required to step

Key secondary outcomes

Open-Close Stepping Test
Timed Up & Go Test
Maximum Walking Speed


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Health adults aged 20 over
Elderly people requiring support
Person who give consent to participate in the study

Key exclusion criteria

Persons who have a history of neuromuscular disorder, orthopedic diseases, dementia and requiring long-term care

Target sample size

220


Research contact person

Name of lead principal investigator

1st name MASAYA
Middle name
Last name TAKI

Organization

Japan Community Health care Organization Chukyo Hospital

Division name

Rehabilitation center

Zip code

457-8510

Address

1-1-10 Sanjo,Minami-ku,Nagoya,Aichi,Japan

TEL

052-691-7151

Email

taki-masaya@chukyo.jcho.go.jp


Public contact

Name of contact person

1st name MASAYA
Middle name
Last name TAKI

Organization

Japan Community Health care Organization Chukyo Hospital

Division name

Rehabilitation center

Zip code

457-8510

Address

1-1-10 Sanjo,Minami-ku,Nagoya,Aichi,Japan

TEL

052-691-7151

Homepage URL


Email

taki-masaya@chukyo.jcho.go.jp


Sponsor or person

Institute

Japan Community Health care Organization Chukyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Community Health care Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Community Health care Organization

Address

3-22-12 Takanawa,Minato-ku,Tokyo,Japan

Tel

03-5791-8220

Email

iryoka@jcho.go.jp


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

2021 Year 06 Month 29 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

Preinitiation

Date of protocol fixation

2021 Year 04 Month 08 Day

Date of IRB

2021 Year 06 Month 21 Day

Anticipated trial start date

2021 Year 07 Month 02 Day

Last follow-up date

2024 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 06 Month 29 Day

Last modified on

2021 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051050


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name