UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034629
Receipt number R000039431
Scientific Title Vertification of load on sacroiliac joint and ligament around the joint using finite element method
Date of disclosure of the study information 2018/10/24
Last modified on 2019/10/25 20:18:37

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Basic information

Public title

Vertification of load on sacroiliac joint and ligament around the joint using finite element method

Acronym

Vertification of load on sacroiliac joint and ligament around the joint

Scientific Title

Vertification of load on sacroiliac joint and ligament around the joint using finite element method

Scientific Title:Acronym

Vertification of load on sacroiliac joint and ligament around the joint

Region

Japan


Condition

Condition

Healthy control

Classification by specialty

Orthopedics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine load on the sacroiliac joint during gait using simulation by Finite Element Method

Basic objectives2

Others

Basic objectives -Others

Biomechanics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

load on the sacroiliac joint and the ligament around the joint the in each phase of gait

Key secondary outcomes

kinematics in lower limb
kinetics in lower limb


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Healthy control
(2) Participating in the previous study "The coordination in upper and lower limbs and trunk during gait in patients with hemiparesis"
(3) Measurement was underwent in the period from November, 2015 to August, 2017.

Key exclusion criteria

(1) Having a previous history of central nervous system disorder and disorder of peripheral nerve
(2) Having a previous history of bone and joint disease in lower limb

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-Ichi Izumi

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code


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
Middle name
Last name Yusuke Sekiguchi

Organization

Tohoku University Hospital

Division name

Department of Rehabilitation

Zip code


Address

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

TEL

0227177677

Homepage URL


Email

yusuke.sekiguchi.b2@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

no Funding Source

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


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

2018 Year 10 Month 24 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

Main results already published

Date of protocol fixation

2018 Year 10 Month 24 Day

Date of IRB

2018 Year 10 Month 26 Day

Anticipated trial start date

2018 Year 10 Month 24 Day

Last follow-up date

2019 Year 10 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We simulate laod on sacroiliac joint in each phase during gait using the finite element model of sacroiliac joint.

When the simulation is underwent, the data of hip joint moment during gait, which has been measured and analyzed using three dimensional motion analysis system in department of Rehabilitaion, Tohoku University Hospital, is used.


Management information

Registered date

2018 Year 10 Month 24 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=R000039431


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name