The effect of a novel orthotic device on the physical activity levels in the daily life of patients with medial knee osteoarthritis
- Conditions
- M17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00009392
- Lead Sponsor
- Funktionsbereich BewegungsanalytikKlinik und Poliklinik für Allgemeine Orthopädie und TumororthopädieUniversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 52
Eligible adults will be required to have clinical KOA according to the American College of Rheumatology guidelines, with knee pain = 4 days per week for =3 months
Exclusion criteria will be:
- Rheumatoid arthritis or any other form of inflammatory arthritis (e.g. crystal arthropathy)
- Diabetes
- Knee replacement, or a scheduled replacement surgery within 3 months in affected leg from or before the beginning of study participation.
- Medical conditions, which could interfere with the activity and test performance, such as neurologic conditions or severe cardiovascular disease.
- Use of ambulatory aid (single straight cane)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical activity levels during daily living:<br>The amount of steps (walking, running and stairclimbing), amount of repititions (cycling) or time spent within postures (standing or sitting/lying) will be measured with two different activity monitors (SAM, Orthocare Innovations and the Axivity3 (Axivity)) during one week of monitoring prior to the intervention. In addition, another week of activity monitoring will take place during the last (sixth) week of the intervention period.
- Secondary Outcome Measures
Name Time Method A gait analysis will be conducted to examine biomechanical parameters of gait (external knee adduction moment, knee adduction angular impulse, knee flexion moment).<br>Physical functioning will be measured by two functional tests: the TUGT and the SCT. The amount of time required to perform the test will be used as outcome measure. In addition, physical function and pain will be assessed by the KOOS. This will be a score from 0 to 100, where 0 represents the optimal score. These measurements will be performed in the movement lab prior to the intervention. Furthermore, the test battery will be performed again after the 6-week intervention.<br>