The aim of the study is to evaluate the validity and reproducibility of the ambulatory system, containing IFS*s and IMS*s, with respect to a reference system, to measure the frontal knee moment during gait in patients with osteoarthritis. As a…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure of the study is the difference in frontal knee moment,
measured with the ambulatory system versus the reference system.
Secondary outcome
Secondary study parameter is the knee angle.
Background summary
Osteoarthritis (OA) of the knee is an age-related degenerative joint disease.
It affects a substantial part of the elderly population, causing limitations in
daily physical functioning. The netto frontal knee moment (i,e, the external
adduction/abduction moment) is directly related to the load in the knee. Its
value during gait is often used as an identifier of disease severity and
evaluation of treatment. In a research environment it is usually estimated from
using force plates and optoelectronic measurements in a gait laboratory.
However, such specialized equipment limits clinical use of this method.
Alternatively, an ambulatory measurement system can be used, based on
instrumented force shoes (IFS) and inertial and magnetic sensors (IMS). Such
systems are increasingly relevant in clinical practice and need to be
validated.
Study objective
The aim of the study is to evaluate the validity and reproducibility of the
ambulatory system, containing IFS*s and IMS*s, with respect to a reference
system, to measure the frontal knee moment during gait in patients with
osteoarthritis. As a reference, a force plate and optoelectronic marker system
will be used.
Study design
This is a observational cross-sectional study. Measurements will be performed
in the gait laboratory of the VU University Medical Center in Amsterdam. 20
patients will be measured in a first session using the ambulant and the
reference system, as well as force shoes and normal shoes, to investigate the
validity; 10 patients will be measured a second time to determine
reproducibility.
Study burden and risks
Patients will be asked to walk a 10m walkway at self-selected speed, wearing
IFS and normal shoes, IMS and marker clusters attached to the segments of the
lower extremities. The measurements are non-invasive. Markers, sensors and
cables may somewhat increase the burden during the measurements compared to
normal walking. During walking, pain and fatigue could occur, however, the risk
of pain will be minimal. Patients can quite the measurements if pain will
occur. The practical relevance of this study is that validation of the
ambulatory system in a clinical situation may help to introduce such systems in
clinical practice. in order to provide more insight in the frontal knee moment
in OA patients, and to be used in evaluation of treatment of OA.
Postbus 7057
1007 MB Amsterdam
Nederland
Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Diagnose of knee osteoarthritis (uni- or bilateral)
Between 40 and 75 years of age
Exclusion criteria
Poly-arthritis,
Presence of rheumatoid arthritis or other systemic inflammatory arthropathy,
Knee surgery within the last twelve months or a history of knee arthroplastic surgery,
Inability to understand the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23052.029.08 |