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STABILO: a randomised controlled trial of knee joint stabilisation therapy in osteoarthritis of the knee

STABILO: a randomised controlled trial of knee joint stabilisation therapy in osteoarthritis of the knee - STABILO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33836
Enrollment
120
Registered
2009-03-30
Start date
2009-04-17
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arthrosis osteoarthritis

Interventions

Experimental intervention The experimental intervention comprises a 12-week exercise therapy program aimed at 1) improving the knee joint stabilisation process, 2) muscle strengthening and 3) functi

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All potential participants* eligibility will first be assessed by a physiatrist, using the following inclusion criteria: - diagnosis of knee OA according to the clinical ACR criteria, i.e.: knee pain and at least three of the following six: age > 50 years, morning stiffness

Exclusion criteria

Exclusion criteria: Co-morbidity which affects functional ability

Design outcomes

Primary

MeasureTime frame
The primary outcome measure in this RCT is self-reported physical functioning as assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC-pf is a commonly used questionnaire to assess the physical functioning of patients with OA, and has been shown to be reliable, valid and sensitive to change.

Secondary

MeasureTime frame
A number of secondary outcome measures are included in the study, reflecting both the assessment of disabilities in specific daily activities, the patient perspective, and relevant biomechanical factors. These measures are: perceived global effect (7-point Likert scale), pain intensity (0-10 NRS), stiffness (WOMAC), fatigue (0-10 NRS), Irrgang*s and Felson*s self-reported knee joint instability scales, questionnaires on rising and sitting down, walking and stair climbing, proprioception, laxity, isokinetic muscle strength of the upper leg (BioDex) and frontal plane alignment of the knee (goniometer). Body length and weight will be collected at all time points to assess changes in Body Mass Index

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)