Trial document




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  DRKS00009392

Trial Description

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Title

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

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Trial Acronym

KNEEMO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

There are currently a number of orthotic interventions available for the treatment of knee osteoarthritis. Their effectiveness is generally examined in a lab-based setting. The effect of the devices in the daily life of patients often remains unknown. Recently a new device has been introduced: an ankle-foot orthosis. Despite promising results in lab testing, the potential benefits of the orthotic has not been investigated in the daily life of patients. Therefore, we aim to examine whether the use of an ankle-foot orthosis improves the physical activity of knee osteoarthritis patients in their day-to-day life. In addition, we would like to assess how the device alters a patient's gait, pain and functional status.
Patients will be asked to wear two activity monitors for one week. These monitors, worn around the ankle and taped to the upper leg, are relatively small and considered to be unobtrusive. They will then be asked to visit the laboratory where a number of tests will be performed to assess their gait, pain and functional status. The ankle-foot orthosis will be given to each patient and the tests will be performed again to assess the immediate effects. For the next 6 weeks, patients will be instructed to wear the device. During the final week, the activity monitors will be worn again. Finally, the lab-based measurements will be performed again upon completion of the 6 week intervention to examine the longer-term effects.

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Brief Summary in Scientific Language

Current literature reports inconclusive results over the effects of orthotic interventions on lower limb biomechanics, and clinical outcomes such as physical functioning and pain. Moreover, no study has objectively examined the effect of orthotics on physical activity in the daily life of KOA patients. Therefore, this study aims to examine the effect of an orthotic intervention on accelerometer-measured activity levels of knee osteoarthritis patients. Furthermore, to assess how the use of orthotics alters pre-specified biomechanical parameters of gait, physical functioning and pain.
A randomized controlled trial will be performed. After the first week of activity monitoring, patients will perform gait analysis, various functional tests and complete the KOOS questonaire before and after receiving the orthotic intervention. They will be instructed to wear this for 6 weeks. Compliance to the intervention will be monitored using a specialised thermo sensor which will be incorporated into the device. During the last week of the intervention period, the activity levels will again be monitored and compared to the pre-intervention activity levels. At the end of the sixth week, the lab measurements will be repeated to examine the midterm effects of the intervention on biomechanics, function and pain.

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Organizational Data

  •   DRKS00009392
  •   2015/12/03
  •   [---]*
  •   yes
  •   Approved
  •   2015-475-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1174-8184 
  •   DRKS00008735  ((DRKS00008735 + DRKS00009392 sind Teilstudien des KNEEMO-Forschungsprojektes/are substudies of the KNEEMO research project) )
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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   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:
    Stepwatch Activity Monitor (SAM, Orthocare Innovations) and the Axivity3 (Axivity)
    Furthermore, they will be required to execute a gait analysis, Timed Up and Go Test, a Stair Climb Test and fill in the KOOS questionnaire to assess their physical function and pain during daily living
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/01
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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)

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Addresses

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    • Funktionsbereich BewegungsanalytikKlinik und Poliklinik für Allgemeine Orthopädie und TumororthopädieUniversitätsklinikum Münster
    • Mr.  Prof.  Dieter  Rosenbaum 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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    •   [---]*
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    •   [---]*
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    • Institut für Experimentelle Muskuloskelettale Medizin (IEMM),Universitätsklinikum Münster
    • Mr.  M.Sc  Maik  Sliepen 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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    • Institut für Experimentelle Muskuloskelettale Medizin (IEMM),Universitätsklinikum Münster
    • Mr.  M.Sc  Maik  Sliepen 
    • Albert-Schweitzer Campus 1, Gebäude D3
    • 48129  Münster
    • Germany
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Sources of Monetary or Material Support

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    • European CommissionMarie SkÅ‚odowska -Curie Innovative Training Networks
    • Ms.  Sandrine  Jacobs 
    • Unit REA-A1
    • B-1049  Brussels
    • Belgium
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/01
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* This entry means the parameter is not applicable or has not been set.