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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 March 2017
Main ID:  ACTRN12617000258358
Date of registration: 20/02/2017
Prospective Registration: Yes
Primary sponsor: University of Physical Education in Krakow
Public title: The role of gait determinants in people with knee osteoarthritis in relation to results of healthy people
Scientific title: The role of gait determinants in the mechanism of limiting oscillation of center of gravity in people with knee osteoarthritis in relation to results of healthy people
Date of first enrolment: 3/04/2017
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  http://www.anzctr.org.au/ACTRN12617000258358.aspx
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
gonarthrosis
Intervention(s)
In all participants is planned single measure of gait analysis.

The first author will enroll 50 patients from a list of patients for total knee replacement. Persons qualified for the research were patients of the Department of Orthopedic and Trauma Surgery of Gabriel Narutowicz Municipal Hospital in Krakow, Poland, who will have total knee replacement.

The qualification for research group will be based on the simple randomisation. Allocation of patients to the group will be decided upon the coin-tossing. Heads – person is participating in the research, tails – person does not take part in the research. Subjects for the research will be always qualified by the same person (the first author). This is part of screening prior to enrolment to ensure a random selection of patients are included

1. Measurement of kinematic and kinetic gait parameters based on a three-dimensional motion analysis, with the use of the Vicon 250 system together with a dynamometric platform. The analysis will cover:
-angular changes in 3 planes of motion of knee, hip and ankle joints
-changes in the length of selected muscles
- changes in ground-reaction forces
-spatio-temporal parameters: the number of steps per minute, single and double support time, stride length and time, gait velocity

2. The knee function assessment with the use of the Lysholm scale will be performed as well as the WOMAC assessment scale.

Vicon 250 system
Vicon 250 system, as a research tool, allows for an objective assessment of gait and processing of the obtained kinematic and spatio-temporal parameters. It consists of five cameras, a set of 39 passive markers and data station.
Small markers (25 mm diameter) coated with reflective material, adheres to the skin at characteristic points of the bone and joint axes. Camera emit flashes at a frequency of 120 Hz with a wavelength at the border of the infrared and visible light, which when reflected from passive markers back to the camera and are recorded by the measuring system. The resulting two-dimensional images from the cameras are processed in the station on the three-dimensional image data (Workstation, Body Builder, Polygon)
Prior to the registration gait through the system Vicon 250, each respondent will be able to freely walk along the 20m path, any number of times during 30 min in order to adapt to the environment and the equipment used. Proper phase of the study will consist of a 6-times passage of pathh with natural speed.
For each patient 30 steps with a stabilized, natural speed will be selected, in order to characterize the individual gait pattern. The collected data will be subjected to computer analysis. On the basis of anthropometric measurements will be modeled gait respondents in the application BodyBulider and then visualized in the form of a research report in the Polygon.

Overall duration of the examination– 2 hours:
1. 1 hour to prepare the patient - affixing the markers on the skin, getting used to the system and markers
2. 1 hour measurements - several times crossing the 20 meter path
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
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