<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445350</url>
  </required_header>
  <id_info>
    <org_study_id>StPoltenUAS</org_study_id>
    <nct_id>NCT04445350</nct_id>
  </id_info>
  <brief_title>Motor Learning in Knee Osteoarthritis</brief_title>
  <acronym>MLKOA</acronym>
  <official_title>Motor Learning in Knee Osteoarthritis Therapy - A New Rehabilitation Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Pölten University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danube University Krems</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karl Landsteiner University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Orthopedic Hospital Speising</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Pölten University of Applied Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-surgical treatment options, like exercise therapy, show excellent short-term effects&#xD;
      regarding pain reduction and improvement of knee function. However, mid- and long-term&#xD;
      effects are missing so far. This might indicate that long-lasting changes in motor-skill&#xD;
      performance (Motor Learning) have not occurred. Motor learning is associated with permanent&#xD;
      changes in the capability for skilled movement behavior avoiding unfavorable joint loads and&#xD;
      inappropriate muscle activation patterns, leading to compensatory movement strategies.&#xD;
      One-sided and high repetitive loads in the knee joint could be one reason for the progression&#xD;
      of knee osteoarthritis. Physiotherapeutic strategies should therefore be able to stimulate&#xD;
      motor learning processes. In physiotherapy, motor learning can be optimized by using&#xD;
      instructions and feedback, targeting an external focus of attention, when learning specific&#xD;
      movement patterns. This study investigates the effects of a 12 week exercise therapy program,&#xD;
      using an external focus of attention, on functional and biomechanical parameters in patients&#xD;
      with knee osteoarthritis. To measure possible changes, functional measurements are taking&#xD;
      place at baseline, after 6, 12 and 24 weeks. The biomechanical measurements (3D gait&#xD;
      analysis) are taking place at baseline, after 12 and 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>3D gait analysis during walking</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Osteoarthritis Outcome Score (change over a period of 6 month with 4 measurement dates)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Questionnaire; Minimum value: 0 (highest limitation), Maximum: 100 (no limitation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Star Excursion Balance Test (change over a period of 6 month with 4 measurement dates)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>An established test to determine movement control and balance ability. The test person stands on one leg and will is asked to stretch the non supporting leg as far as possible in the directions presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Isometric strength tests (change over a period of 6 month with 4 measurement dates)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Measures the isometric force of the knee extensors, knee flexors, hip abductors, hip extensors and hip external rotators with a portable dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six minute walking test (change over a period of 6 month with 4 measurement dates)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>The six minute walking test is a reliable measuring tool to examine the distance a person can walk in a given time period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Lower Extremity Biomechanics</condition>
  <condition>Physiotherapy</condition>
  <arm_group>
    <arm_group_label>External focus of attention training program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internal focus of attention training program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>External Focus Of Attention</intervention_name>
    <description>Instructions and feedback are used to direct the learner's focus to an external source (e.g. the effect the intended movement has) promoting long-term learning by stimulating automatic cognitive control processes.</description>
    <arm_group_label>External focus of attention training program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internal Focus Of Attention</intervention_name>
    <description>In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.</description>
    <arm_group_label>Internal focus of attention training program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kellgren-Lawrence-Score 1-3&#xD;
&#xD;
          -  BMI &lt; 33&#xD;
&#xD;
          -  Free range of motion in the knee joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Activated knee osteoarthritis&#xD;
&#xD;
          -  Lower extremity surgery in the past 6 weeks&#xD;
&#xD;
          -  Intake or injection of corticosteroids in the past 3 month&#xD;
&#xD;
          -  Long-term medication non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Barbara Wondrasch, PhD</last_name>
    <phone>+43/676/847 228 583</phone>
    <email>barbara.wondrasch@fhstp.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sankt Pölten University of Applied Sciences</name>
      <address>
        <city>Sankt Pölten</city>
        <state>Lower Austria</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Unger, Dr.</last_name>
      <phone>+43/2742/313 228 246</phone>
      <email>nicole.unger@fhstp.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Birgit Bauer, Dr.</last_name>
      <phone>+43/2742/313 228 371</phone>
      <email>birgit.bauer@fhstp.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Pölten University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>Wondrasch</investigator_full_name>
    <investigator_title>FH-Professor Barbara Wondrasch, PhD</investigator_title>
  </responsible_party>
  <keyword>Physiotherapy</keyword>
  <keyword>External Focus Of Attention</keyword>
  <keyword>Knee Adduction Moment</keyword>
  <keyword>Gait Analysis</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Motor Learning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445350
org study id: StPoltenUAS
nct id: NCT04445350
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Non-surgical treatment options, like exercise therapy, show excellent short-term effects
      regarding pain reduction and improvement of knee function. However, mid- and long-term
      effects are missing so far. This might indicate that long-lasting changes in motor-skill
      performance (Motor Learning) have not occurred. Motor learning is associated with permanent
      changes in the capability for skilled movement behavior avoiding unfavorable joint loads and
      inappropriate muscle activation patterns, leading to compensatory movement strategies.
      One-sided and high repetitive loads in the knee joint could be one reason for the progression
      of knee osteoarthritis. Physiotherapeutic strategies should therefore be able to stimulate
      motor learning processes. In physiotherapy, motor learning can be optimized by using
      instructions and feedback, targeting an external focus of attention, when learning specific
      movement patterns. This study investigates the effects of a 12 week exercise therapy program,
      using an external focus of attention, on functional and biomechanical parameters in patients
      with knee osteoarthritis. To measure possible changes, functional measurements are taking
      place at baseline, after 6, 12 and 24 weeks. The biomechanical measurements (3D gait
      analysis) are taking place at baseline, after 12 and 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)
time frame: Baseline, 12 weeks, 24 weeks
description: 3D gait analysis during walking
measure: Knee Osteoarthritis Outcome Score (change over a period of 6 month with 4 measurement dates)
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Questionnaire; Minimum value: 0 (highest limitation), Maximum: 100 (no limitation)
measure: Star Excursion Balance Test (change over a period of 6 month with 4 measurement dates)
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: An established test to determine movement control and balance ability. The test person stands on one leg and will is asked to stretch the non supporting leg as far as possible in the directions presented.
measure: Isometric strength tests (change over a period of 6 month with 4 measurement dates)
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Measures the isometric force of the knee extensors, knee flexors, hip abductors, hip extensors and hip external rotators with a portable dynamometer
measure: Six minute walking test (change over a period of 6 month with 4 measurement dates)
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: The six minute walking test is a reliable measuring tool to examine the distance a person can walk in a given time period.
arm group label: External focus of attention training program
arm group type: Experimental
description: The intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention.
arm group label: Internal focus of attention training program
arm group type: Active Comparator
description: The control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention.
intervention type: Other
intervention name: External Focus Of Attention
description: Instructions and feedback are used to direct the learner's focus to an external source (e.g. the effect the intended movement has) promoting long-term learning by stimulating automatic cognitive control processes.
arm group label: External focus of attention training program
intervention type: Other
intervention name: Internal Focus Of Attention
description: In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.
arm group label: Internal focus of attention training program
criteria: 
gender: All
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: No
last name: Barbara Wondrasch, PhD
phone: +43/676/847 228 583
email: barbara.wondrasch@fhstp.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: St. Pölten University of Applied Sciences
investigator full name: Wondrasch
investigator title: FH-Professor Barbara Wondrasch, PhD
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee