To evaluate the effectiveness of the WALK gait retraining program, compared to a standardised treatment protocol based on the KNGF (royal Dutch association of physiotherapists) guidelines, in patients with clinical symptoms of mild to moderate knee…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Between group difference in change in pain / function score between baseline
and 3 months follow-up.
Secondary outcome
Secondary outcomes are OMERACT*OARSI set of responder criteria, KOOS, NRS pain,
EQ-5D, ICOAP, *need for TKA* OARSI-criteria, gait parameters as assessed by
gait analyses (duration of full extension and quadriceps muscle activity during
midstance of walking cycle) , and medication use. To get more insight in which
specific patients will respond on the current intervention also the HADS,
Central Sensitization Inventory, pain drawing form and pain cognition list will
be evaluated.
Background summary
Osteoarthritis (OA) of the knee is associated with changes in gait pattern.
These changes result in a dysfunctional gait pattern, that by itself can worsen
the OA symptoms. Main goal of the Walking ALteration for Knee osteoarthritis
(WALK) gait correction program is to achieve full passive and active knee
extension. This is a prerequisite for quadriceps relaxation in early mid stance
in the gait cycle, thus reducing the tibiofemoral forces during a considerate
period of the gait cycle. Our hypothesis is that adaptation of the gait pattern
through gait retraining can relieve the symptoms in knee OA.
Study objective
To evaluate the effectiveness of the WALK gait retraining program, compared to
a standardised treatment protocol based on the KNGF (royal Dutch association of
physiotherapists) guidelines, in patients with clinical symptoms of mild to
moderate knee OA and a knee extension deficit. The hypothesis is that the WALK
gait retaining program is more effective to treat patients with symptoms of
mild to moderate knee OA (superiority study).
Study design
Open-labeled randomized controlled trial.
Intervention
Patients will be randomized in a) WALK gait retraining program or in b)
physiotherapy with a standardised treatment protocol, in accordance with the
Dutch guideline for physiotherapists on knee OA (usual care).
Study burden and risks
The WALK gait retraining program has been shown to have favourable effects on
OA symptoms in mild to moderate knee OA in the WALK study pilot. This RCT is
executed to compare this method to current physiotherapeutic intervention.
Participating subjects will not be exposed to any additional risks.
Besides the treatment, subjects will undergo limited testing procedures;
functional outcome is assessed with questionnaires, and measurements of gait
parameters are performed with video based gait analysis, using adhesive markers
on anatomical landmarks, and skin electrodes for surface EMG measurements.
Ds Fliednerstraat 1
Eindhoven 5631 BM
NL
Ds Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
- Symptomatic knee OA according to the clinical ACR criteria
- Radiographic OA, according to Kellgren and Lawrence grade 1, 2 or 3
- Flexion contracture of 5 degrees or more, measured with a goniometer
Exclusion criteria
- Medial or lateral instability of the knee,
o Medial or lateral joint space opening of * 5 mm in 20° of knee flexion is considered as unstable.
- Symptomatic bilateral knee OA
- Intra-articular injection of the knee, in the previous 3 months
- Previous peri-articular osteotomy of the affected knee
- Symptomatic OA of hip or ankle
- Co morbidity which disables the function of the lower extremity
- Rheumatoid Arthritis or other inflammatory joint disease
- Physical therapy for current complaints during last 3 months
- Insufficient command of the Dutch language
- Legally incompetent adults
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 | NL58142.015.16 |