A) To evaluate the use of real-time visual and audio feedback on the knee adduction moment and on kinematic patterns during gait in patients with knee osteoarthritis to decrease the biomechanical load on the knee via implicit learning and explicit…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are change in external knee adduction moment (KAM)
between different conditions. KAM will be measured during the various gait
modification conditions (study A: 1. baseline; 2. KAM feedback without
kinematic instructions, audio and visual feedback; 3. Kinematic feedback
without further instructions (toe-out or -in, step width and medial thrust); 4.
KAM feedback with additional verbal kinematic instructions about an effective
gait pattern that can be sustained in daily life: 5. maintaining the pattern
from 4. without any feedback) and during and after the training sessions (study
B: 1. baseline; 2. try to replicate the pattern learned in study A without
feedback; 3. KAM feedback with kinematic instructions from study A; 4.
maintaining the pattern from 3. without feedback; follow-up after 3 and 6
months). Linear mixed models will be used to calculate statistical differences.
Pain as measured by the numeric rating scale and WOMAC questionnaire will also
be a primary outcome.
Secondary outcome
Secondary parameters will include external knee flexion moment (KFM), and
kinematic pattern (joint angles and temporal-spatial parameters) as measured by
the GRAIL; these will be assessed during the different gait modification
patterns (as for the KAM). EMG cocontraction is also a secondary outcome.
Background summary
Real-time visual and audio feedback of the gait pattern is assumed to be
effective for gait retraining in patients with osteoarthritis of the knee
(KOA). Modification of the gait pattern results in a change in knee joint
loading. The external knee adduction moment (KAM) is considered to be a good
surrogate measure of internal loading on the medial side of the tibiofemoral
condyles. KOA patients with medial compartment OA often show a higher KAM
compared to healthy subjects. In healthy subjects it has been shown that direct
real-time visual feedback of the KAM was effective in reducing the knee joint
loading. A gait training protocol with direct KAM feedback in which patients
can develop preferred individual kinematic strategies needs to be developed.
Study objective
A) To evaluate the use of real-time visual and audio feedback on the knee
adduction moment and on kinematic patterns during gait in patients with knee
osteoarthritis to decrease the biomechanical load on the knee via implicit
learning and explicit instructions; (B) To provide proof-of-concept for the use
of real-time feedback as a clinical intervention on gait retraining to decrease
the biomechanical load on the knee in patients with (medial compartment) knee
osteoarthritis during a 6 weeks training and 3 and 6 months follow-up.
Study design
Cross-sectional observational study (A) and uncontrolled trial (B). In the
first study (A) a biofeedback algorithm using computer modelling will be tested
on its feasibility in a cross-sectional observational study to establish
measurement capability and quality in patient with OA of the knee (n=41). In a
second study (B) a small-scale exploratory intervention (uncontrolled trial)
will be carried out during 6 weeks to provide evidence for real-time feedback
as an intervention in modifying gait in a sub-sample of the previous study 30.
Follow-up measurements will be carried out 3 and 6 months after the end of the
training. Modification of knee load and gait characteristics will be assessed
by 3D motion analysis on the GRAIL (Gait real-time analysis interactive lab
including an instrumented treadmill, a motion capture system and a semi
cylindrical screen with virtual reality environment and real-time gait
feedback).
Intervention
Training protocol for gait modification once every week during 6 weeks,
including feedback on the external knee adduction moment (KAM) and advice on
home training.
Study burden and risks
Potential participants of the study are registered as members of the AMS-OA
cohort (Reade) and selected patients from our own database (via the newsletter
and local newpapers) will be invited to participate the study. If they pass the
inclusion criteria and are willing to participate, they will be invited to come
to the VUmc for a visit with the researcher. A final decision on eligibility
will be made, based on the inclusion criteria. Participants will be assessed
during a part of the day (maximum of three hours in study A, one hour in study
B). In that time they will complete questionnaires and perform
physical-performance tests, and walk on the treadmill with different gait
modification conditions. To protect participants from falling, subjects will
wear a safety harness during the walking trials. During the measurements,
participants will be asked to modify the gait pattern. The risk of gait
modification on side effects is negligible. Total risk of adverse events during
the assessments and during walking on the treadmill is negligible. Also during
the training, the risk on adverse events is negligible. Periods of rest will be
allowed during/ between the measurements to prevent fatigue. Patients will also
be asked about their pain levels and the training or measurements can be
shortened if necessary in response to increasing pain (although from previous
literature in the field we do not anticipate this problem). Patients will also
be made aware that they are free to withdraw from the study at any time without
giving a reason.
VUMC De Boelelaan 1118
Amsterdam 1081 HZ
NL
VUMC De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the present study (A and B) are knee osteoarthritis on the medial compartment based on the ACR criteria, age between 50 and 75 years old, Body Mass Index (BMI) between 20 and 30 kg/m2, maximum score of 7 on the numeric rate scale (NRS) for pain intensity during the past two weeks.
Additional inclusion criteria for study B is satisfaction with applied gait modification pattern in study A, willingness to further learn this pattern and clear improvement in knee adduction moment (approximately 10% reduction). This will be at the discretion of the physiotherapist involved who will have the final decision on inclusion.
Exclusion criteria
Total knee replacement, rheumatoid arthritis or any other form of inflammatory arthritis (i.e., crystal arthropathy or septic arthritis). Similarly patients with hip osteoarthritis will be excluded, as will people with poor vision that would prevent them from being able to see the visual feedback. Patients who are already included in any other experimental research study (including but not limited to the Vitamin D study and the COOA study) will also be excluded.
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 | NL51889.029.15 |