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The effect of a novel orthotic device on the physical activity levels in the daily life of patients with medial knee osteoarthritis

The effect of a novel orthotic device on the physical activity levels in the daily life of patients with medial knee osteoarthritis - KNEEMO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009392
Enrollment
70
Registered
2015-12-03
Start date
2016-02-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

M17

Interventions

Group 1: Patients will receive the 'Agilium Freestep' ankle-foot orthosis (Ottobock) for 6 weeks. During the last week, their physical activity levels will be monitored using two activity monitors:

Sponsors

Funktionsbereich BewegungsanalytikKlinik und Poliklinik für Allgemeine Orthopädie und TumororthopädieUniversitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Physical activity levels during daily living: 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

MeasureTime frame
A gait analysis will be conducted to examine biomechanical parameters of gait (external knee adduction moment, knee adduction angular impulse, knee flexion moment). 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.

Countries

Germany

Contacts

Public ContactMaik Sliepen

Institut für Experimentelle Muskuloskelettale Medizin (IEMM),Universitätsklinikum Münster

mpl.sliepen@uni-muenster.de+49 251 83 52975

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026