Trial document




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  DRKS00004941

Trial Description

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Title

Evatuation of long-term biomechanical effects of knee support in subjects with knee osteoarthritis

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Trial Acronym

Kniebandage

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URL of the Trial

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Brief Summary in Lay Language

Knee arthritis is associated with pain and leads to locomotion limitations. Indeed, gait kinematics and neuromuscular activation are altered during walking and running. The use of knee support (bandage) helps reducing the pain and allows returning to a normal locomotion.
The aim of the study is to investigate the long term effects of such a knee support after several weeks of use, based on a comparison with a control group (receiving no knee support).

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Brief Summary in Scientific Language

Knee arthritis impairs gait kinematics and neuromuscular activation of the relevant leg muscles during walking or running (Block & Shakoor, 2010; Ornetti et al., 2010). It has been already showed that the use of such knee support could reduce knee pain and change some kinematical parameters of locomotion (Schween et al., in prep.).
However, it remains unknown if such short term effects would still be observable or even improved after wearing the bandage over a longer period. Therefore, an intervention study over 6 weeks with participants suffering from knee arthritis on only one leg and with pre- and post- measurements including the relevant gait kinematics, kinetics and neuromuscular parameters would be of interest.
The aim of the study is to understand if knee pain reduction and improved walking biomechanics classically reported when wearing a bandage could also be optimized over a long period of time.

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Organizational Data

  •   DRKS00004941
  •   2013/06/17
  •   [---]*
  •   yes
  •   Approved
  •   184/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1142-2392 
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Health Condition or Problem studied

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

  •   Arm 1: Intervention group, subjects with medial knee arthritis, between 35 - 60 years old. Subjects will be tested with a pre and post measurements design by measuring gait kinematics, kinetics and neuromuscular control during walking, running, walking up and down stairs. Tests will be performed with and without knee bandage. Prior to these testings, anthropometric data and information related to the daily life activity as well as movement limitations and pains due to the knee will be collected by means of a questionnaire.
    During the 6 weeks training intervention, subjects will have to wear the bandage (GenuTrain, Bauerfeind AG) for at least 6 hours a day, including while doing some physical activity. Subjects will be taught how to wear the bandage during their first visit for the pre-measurement.
  •   Arm 2: Control group, subjects with medial knee arthritis, between 35 - 60 years old. Subjects will be tested with a pre and post measurements design by measuring gait kinematics, kinetics and neuromuscular control during walking, running, walking up and down stairs. Tests will be performed with and without knee bandage.
    Prior to these testings, anthropometric data and information related to the daily life activity as well as movement limitations and pains due to the knee will be collected by means of a questionnaire.
    During the 6 weeks training intervention, subjects will not wear any knee bandage.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

After 6 week knee support the reduction of knee joint load will be compared to a no-treatment control group.
Knee joint load is determined by kinematic and kinetic parameters (adduction, adduction moment, joint stiffness, plantar pressure)
Knee joint controll is determined of muscles surrounding the joint (electromyography).

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Secondary Outcome

After 6 week knee support changes in subjective pain will be compared to a no-treatment control group.
Changes in subjective pain, measured with a Visual Analogue Scale, will be investigated in relation to changes in knee joint load.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2013/06/19
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   60   Years
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Additional Inclusion Criteria

Male and female subjects, medically diagnosed (preferably) medial knee osteoarthritis, aged between 35-60.

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Exclusion Criteria

Disability to go or to run contingent on health problems, neurological diseases, artificial ankle, knee or hip joint, knee support during last 6 month

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Addresses

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    • Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg
    • Mr.  Prof. Dr.  Albert  Gollhofer 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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    • Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg
    • Mr.  Dr.  Guillaume  Mornieux 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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    • Institut für Sport und Sportwissenschaft der Albert-Ludwigs-Universität Freiburg
    • Mr.  Dr.  Guillaume  Mornieux 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bauerfeind AG
    • Mr.  Michael  Ullrich 
    • Triebeser Straße 16
    • 07937  Zeulenroda-Triebes
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.