UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034589
Receipt number R000039428
Scientific Title The characteristics of kinetics in lower limb during ascending and descending long stair in outdoor enviroment
Date of disclosure of the study information 2018/10/29
Last modified on 2019/10/25 20:22:20

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Basic information

Public title

The characteristics of kinetics in lower limb during ascending and descending long stair in outdoor enviroment

Acronym

The characteristics of lower limb power during ascending and descending long stair in outdoor enviroment

Scientific Title

The characteristics of kinetics in lower limb during ascending and descending long stair in outdoor enviroment

Scientific Title:Acronym

The characteristics of lower limb power during ascending and descending long stair in outdoor enviroment

Region

Japan


Condition

Condition

healthy controls

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of the present study is to examine the characteristics of kinetics in lower limb during ascending and descending long stair

Basic objectives2

Others

Basic objectives -Others

Biomechanics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

kinetics in lower limb

Key secondary outcomes



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

40 years-old >=

Gender

Male and Female

Key inclusion criteria

The subjects have the ability to ascend and descend the stair with 200 steps, continuously.

Key exclusion criteria

(1) having pain at a joint in lower limb
(2) having had major orthopae
dic surgery
(3) having orhopaedic surgery and neurologic diseases
(4) having visual deficits
(5) having respiratory and circulatory diseases

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Shin-Ichi
Middle name
Last name Izumi

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

9808575

Address

2-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan

TEL

0227177338

Email

izumis@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Sekiguchi

Organization

Tohoku University Hospital

Division name

Department of Rehabilitation

Zip code

9808575

Address

1-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan

TEL

0227177677

Homepage URL


Email

yusuke5547@yahoo.co.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

NEC 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

Institutional Review Board of Tohoku University School of medicine

Address

2-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.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

2018 Year 10 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

9

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 10 Month 26 Day

Date of IRB

2018 Year 10 Month 26 Day

Anticipated trial start date

2018 Year 10 Month 26 Day

Last follow-up date

2019 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We measured task 1 and 2 using portable three dimensional motion analysis system.

Task 1
Subjects ascend and descend the stair with 202 steps at 80 step/minite in Tohoku University Hospital.Subjects perfom ascending and descending stair at random order. Subjects walk 30m pass way at comfortable speed in indoor enviroment.

Task 2
Subjects ascend and descend the stair with 202 steps at 80 step/minite in Shrine.Subjects perfom ascending and descending stair with 202 step at random order. Subjects walk 30m pass way at comfortable speed in outdoor enviroment.


Management information

Registered date

2018 Year 10 Month 22 Day

Last modified on

2019 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name