Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000258358
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
20/02/2017
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 290986 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gonarthrosis 301740 0
Condition category
Condition code
Musculoskeletal 301438 301438 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 296940 0
Not applicable
Comparator / control treatment
The control group will be the healthy people, aged 40 - 60 years who have no evidence of current dysfunction of musculoskeletal, nervous, circulatory and other diseases affecting the gait pattern. Control sample will count 50 people, of both sexes.
The qualification for control 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).
The healthy participants will also complete the Vicon 250 and WOMAC assessments.
Control group
Active

Outcomes
Primary outcome [1] 300831 0
Kinematic parameters of gait assessed by Vicon system:
1. angular changes knee, ankle and hip joints
2. spatio-temporal measurements
Timepoint [1] 300831 0
Immediately after measurement
Primary outcome [2] 301057 0
Kinetic parameters of gait assessed by Vicon system:
1. ground reaction force
Timepoint [2] 301057 0
Immediately after measurement
Secondary outcome [1] 330979 0
Knee function assessed by WOMAC and Lysholm scales
Timepoint [1] 330979 0
Immediately after measurement

Eligibility
Key inclusion criteria
Study group:
1. Diagnosed advanced osteoarthritis of the knee (stage III / IV)
2. Score < 60 in the Lysholm scale,
3. Score > 45 in the WOMAC scale,
4. Written consent of the patient to participate in research,
Control group:
1. Lack of injuries and diseases of the musculoskeletal system and neurological diseases.
2. Written consent of the patient to participate in research,
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Study and control group
1. Age below 40 and above 60 years
2. 30 < BMI <19
3. Identified coexisting diseases such. neurological, cardiac, advanced diabetes, uncontrolled high blood pressure and other diseases that may affect the gait pattern,
3. acute injuries and inflammation within the motor organs,
4. the overall poor health of the test,

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis of the collected material in the first stage will include testing the normal distribution of variables (Shapiro-Wilk test). Then, depending on the results of the calculated ratios are descriptive statistics such as the arithmetic mean (x) and standard deviation (s) or median and deviation quadrant.
517/5000
Depending on the distribution of the variables for testing the significance of differences between mean values of the variables will be used analysis of variance [ANOVA (F test) verification by test post hoc Tukey, or in the absence of normal distribution of results, the non-parametric test for two dependent samples (Wilcoxon test ). The differences between the curves of changes of angles in a standardized gait cycle in the joints of the lower limbs and spatial movements of the pelvis will be assessed on the basis of an analysis of the profiles.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
31/10/2017
Actual
Date of last data collection
Anticipated
31/10/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8601 0
Poland
State/province [1] 8601 0
Malopolska

Funding & Sponsors
Funding source category [1] 295402 0
University
Name [1] 295402 0
University of Physical Education in Krakow
Country [1] 295402 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
University of Physical Education in Krakow
Al. Jan Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 294226 0
None
Name [1] 294226 0
None
Address [1] 294226 0
None
Country [1] 294226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296737 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 296737 0
Ethics committee country [1] 296737 0
Poland
Date submitted for ethics approval [1] 296737 0
10/02/2016
Approval date [1] 296737 0
24/02/2016
Ethics approval number [1] 296737 0
13/KBL/OIL/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1392 1392 0 0
/AnzctrAttachments/372217-bioethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 71926 0
Mrs Aleksandra Kulik-Warchala
Address 71926 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 71926 0
Poland
Phone 71926 0
+48126831065
Fax 71926 0
Email 71926 0
[email protected]
Contact person for public queries
Name 71927 0
Katarzyna Ogrodzka
Address 71927 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 71927 0
Poland
Phone 71927 0
+48126831065
Fax 71927 0
Email 71927 0
[email protected]
Contact person for scientific queries
Name 71928 0
Katarzyna Ogrodzka
Address 71928 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 71928 0
Poland
Phone 71928 0
+48126831065
Fax 71928 0
Email 71928 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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