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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034629
Receipt No. 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 2018/10/24

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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
Institute Tohoku University
Institute
Department

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 24 Day
Last follow-up date
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
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.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


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