UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039431