The objective is to develop a reliable and concurrent valid KneeGSN that expresses the knee joint (in)stability during gait in KOA patients.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the study are the responses of the gait kinematics,
gait kinetics and EMG signals (of the main muscles spanning the knee joint)
during and after mechanical perturbations.The responses of the subjects forms
the basis for the development of the dynamic stability measure (GSN).
Secondary outcome
Secondary outcomes of the study are self-reported knee joint instability (Knee
Outcome Survey (KOS) and Knee disability and Osteoarthritis Outcome Score
(KOOS)), postural balance, self-reported functional ability (Western Ontario
and McMaster Universities Arthritis Index (WOMAC), functional performance tests
(Get Up and Go test (GUG), 10-meter walk test), knee joint proprioception,
Varus * Valgus laxity, muscle strength (HUMAC NORM isokinetic knee test) and
disease severity (Kellgren and Lawrence grade (K&L)).
Background summary
Knee osteoarthritis (KOA) is a common disease in elderly. Osteoarthritis
involves progressive degeneration of the cartilage, which leads to immobility
and pain for the patient. Along with this, a large part of the patients report
knee joint instability during daily activities (like walking). Patients
perceive knee joint instability as a sensation of buckling, shifting or giving
away of the knee joint. Studies suggest that knee joint instability could be a
key concept in explaining initiation and progression of KOA. The lack of trust
in the knee joint may result in a gait compensation mechanism, that alters the
knee mechanics which accelerates further cartilage wear. Currently the concept
of knee joint instability is based on subjective patient reported outcome; or
on static, passive measurements of the laxity of the knee or on postural
balance tests. None of these methods objectively measures the dynamic
instability of the knee joint. A quantitative measure to express knee joint
instability during dynamic tasks (mainly gait) would be helpful to objectively
diagnose instability; to get a better understanding of the mechanisms of
instability in KOA; and to optimize therapy aiming to improve knee joint
stability in patients. Recent developments in experimental gait analysis labs
and the robotic field made it possible to create a measure such as the Gait
Sensitivity Norm (GSN) based on small perturbations during gait. The GSN can
use one or several parameters (gait or knee) as an input. Results of a pilot
study in healthy young subjects illustrate the feasibility of the development
of such a quantitative measure for stability in the knee.
Study objective
The objective is to develop a reliable and concurrent valid KneeGSN that
expresses the knee joint (in)stability during gait in KOA patients.
Study design
An explorative observational study will be performed with in the first study
(A) 20 KOA patients with self-reported instability, 20 KOA patients without
self-reported instability and 20 healthy controls. Dynamic knee joint stability
will be assessed by exposing subjects to perturbations while walking on an
instrumented treadmill in a virtual reality environment (GRAIL system). Gait
kinetics, gait kinematics and electromyography (EMG) of the lower extremity
will be measured to capture the responses of the subjects to these
perturbations. The differences in responses between the groups form the basis
for the KneeGSN. Reliability and concurrent validity of the measure of dynamic
knee joint instability will be evaluated in a second study (B) with 20 KOA
patients (14 with self-reported instability). In study B two measurements will
be performed (a week apart) to test the reliability. Study A will only be one
measurement.
Study burden and risks
The study has a low burden on the study group, because no intervention will be
tested and it involves a common motor task (walking). The risk associated with
this study is small and could only be caused by the instrumented treadmill that
induces small perturbations on the subject. However, these perturbations are
performed in a controlled environment with safety equipment such as a harness
to prevent falling. Other studies which made use of these type of perturbations
were already approved by the METC. There is no direct benefit for the patient.
However, results of this study could provide better insight in the disease and
enables a stronger base (quantitative assessment) for intervention studies
aiming to stabilize the knee (braces, muscle strengthening).
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate the study, a knee osteoarthitis (KOA) subject must meet all of the following criteria:
- Unilateral or bilateral diagnosis of the KOA according to the American college of Rheumatology (ACR) criteria. ACR criteria are age over 50 years, morning stiffness less than 30 minutes, crepitus on active motion, bony tenderness or absence of palpable warmth of synovium.
- Able to walk for 5 minutes without stopping.
- A maximal score of 7 on the numeric scale (NRS) for pain intensity during the past two weeks.
- Body mass index (BMI) between 20 and 35 kg/m2.;The KOA subjects will be assigned to the KOA-I group (group with unstable knees) based on the following criterion:
- Have had the perception of an episode of buckling, shifting or giving way of the knee in the past 4 weeks based on questionnaire (KOS-ADLS).;The KOA subject will be assigned to the KOA-S group (group with stable knees) based on the following criterion:
- Have had no perception of an episode of buckling, shifting or giving way of the knee in the past 3 months on questionnaire (KOS-ADLS).;Healthy controls will be age matched, gender matched and BMI matched with the total KOA group (i.e. similar mean ± standard deviation as total KOA group, except for gender which will be about the same ratio as the total KOA group (+- 3%)).
Exclusion criteria
Potential KOA subject meeting any of the following criteria will be excluded from participation in the study:
- Diagnosed with hip osteoarthritis, rheumatoid arthritis or any other form of inflammatory arthritis (i.e., septic arthritis, crystal arthropathy)
- Has a lower extremity joint replacement.
- Has had a knee related injury last year.
- Not signed an informed consent.;A potential control subject meeting any of the following criteria will be excluded from participation in the study:
- Diagnosed with a musculoskeletal disease.
- Has a lower extremity joint replacement.
- Has had a knee related injury last five years.
- Has knee-related problems.
- Not signed an informed consent.
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 | NL61592.029.17 |