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
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
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
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
