|- candidate number||26813|
|- NTR Number||NTR6996|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-mrt-2017|
|- Secondary IDs|| |
|- Public Title||Walking ALteration for Knee osteoarthritis. |
|- Scientific Title||Walking ALteration for Knee osteoarthritis.
|- ACRONYM||The WALK Study|
|- hypothesis||The WALK gait retraining program is more effective to treat patients with symptomatic mild to moderate knee OA and an extension deficit, compared to a standardised treatment protocol based on the KNGF (royal Dutch association of physiotherapists) guidelines.|
|- Healt Condition(s) or Problem(s) studied||Knee osteoarthritis, Conservative treatment, Knee extension deficit, Physiotherapy|
|- 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.
|- Exclusion criteria||- Medial or lateral instability of the knee, |
- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2018|
|- planned closingdate||1-dec-2020|
|- Target number of participants||144|
|- Interventions||Patients will be randomized in a group |
(a) control group: physiotherapy with a standardised treatment protocol based on the KNGF (royal Dutch association of physiotherapists) guidelines.
(b) index group: WALK gait retraining program.
|- Primary outcome||Between group difference in change in pain score of the KOOS between baseline and 3 months follow-up.|
|- Secondary outcome||- Comparison of percentage of responders according to the OMERACT/OARSI set of responder criteria, during 12 months follow up, in the control and index group. To measure pain and function, the Number Rating Scale for knee pain (NRS) and KOOS physical function will be used, while for global assessment a Likert scale will be used. These outcomes will be assessed during the first 3 months of the study: weekly, and thereafter: at 6, 9 and 12 months after baseline measurement.|
After 3 and 12 months of follow-up groups will be compared concerning change since baseline of:
- Number Rating Scale for knee pain (NRS)
- EQ-5D; Intermittent and Constant OsteoArthritis Pain (ICOAP);
- treatment failure (TKA during follow-up; or in “need for TKA” OARSI-criteria after 12 months; or other surgical interventions of the knee during follow-up (osteotomy of high tibia or low femur; arthroscopic intervention; UKA));
- Range of motion of the knee (ROM)
- gait parameters as assessed by gait analyses
- 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.
|- Timepoints||Baseline, during the first 3 months of the study: weekly, at 6, 9 and 12 month follow-up.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| J.J. Tolk|
|- CONTACT for SCIENTIFIC QUERIES|| J.J. Tolk|
|- Sponsor/Initiator ||Raad van bestuur Máxima Medisch Centrum|
(Source(s) of Monetary or Material Support)
|Máxima Medical Center|
|- Brief summary||Osteoarthritis (OA) of the knee is associated with changes in gait pattern. Our hypothesis is that adaptation of the gait pattern through gait retraining can relieve the symptoms in knee OA. A RCT will be performed to compare the effectiveness of the WALK gait retraining program, compared to a standardised treatment protocol based on the KNGF guidelines, in patients with clinical symptoms of mild to moderate knee OA and a knee extension deficit. Main study endpoints is between group difference in change in pain and function score between baseline and 3 months follow-up. Secondary outcome parameters are gait analysis and functional outcome.
|- Main changes (audit trail)||Ontbrekende informatie niet aangeleverd door onderzoeker.|
|- RECORD||3-mrt-2017 - 13-feb-2018|