<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/NCT02234895</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01313</org_study_id>
    <nct_id>NCT02234895</nct_id>
  </id_info>
  <brief_title>Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis</brief_title>
  <official_title>Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pedorthic Research Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kintec Footlabs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of&#xD;
      life and increased economic burden. Current research has focused on expensive, invasive&#xD;
      treatments, whereas inexpensive conservative treatments have received less attention. One&#xD;
      such treatment is the use of orthotics to reduce pain and increase function in people with&#xD;
      knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and&#xD;
      contradictory, and could benefit from more research taking into account foot posture. This&#xD;
      study aims to compare the use of two orthotics designs in people with knee OA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knee joint load during walking: knee adduction moment</measure>
    <time_frame>Baseline and 2 months</time_frame>
    <description>Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.&#xD;
The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee Pain</measure>
    <time_frame>Baseline and 2 Months</time_frame>
    <description>The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Reported Physical Function</measure>
    <time_frame>Baseline and 2 Months</time_frame>
    <description>The physical function subscale (17 questions) on the WOMAC will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Foot Pain</measure>
    <time_frame>Baseline and 2 Months</time_frame>
    <description>Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participant perceived response to treatment</measure>
    <time_frame>2 Months</time_frame>
    <description>At follow-up for each orthotic, participants will rate overall perceived change in pain and physical function (vs. baseline) on an ordinal scale (1-much worse, 2-slightly worse, 3-same, 4-slightly better, 5-much better). This will be dichotomized into 'improvement' (4 and 5) or 'no improvement'</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Lateral wedge plus medial arch support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lateral wedge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lateral wedge</intervention_name>
    <description>This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.</description>
    <arm_group_label>Lateral wedge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lateral wedge plus medial arch support</intervention_name>
    <description>This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.</description>
    <arm_group_label>Lateral wedge plus medial arch support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of&#xD;
        OA)&#xD;
&#xD;
        ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and&#xD;
        evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment&#xD;
&#xD;
        iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above&#xD;
        the reported population mean.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out&#xD;
        of 10 over previous week) to allow detection of treatment response&#xD;
&#xD;
        ii) knee surgery or intra-articular corticosteroid injection within the previous six months&#xD;
&#xD;
        iii) current or recent (within 4 weeks) oral corticosteroid use&#xD;
&#xD;
        iv) any muscular, joint or neurological condition affecting lower limb within the past 6&#xD;
        months&#xD;
&#xD;
        v) ankle/foot pathology or pain that precludes the use of orthotics&#xD;
&#xD;
        vi) current use of foot orthotics&#xD;
&#xD;
        vii) use of footwear unable to accommodate an orthotic&#xD;
&#xD;
        viii) unable to walk without a gait aid&#xD;
&#xD;
        ix) inability to speak English or have a family member present to translate (required for&#xD;
        the validity of the questionnaires)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael A Hunt, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia; University Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 6, 2016</last_update_submitted>
  <last_update_submitted_qc>June 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>knee</keyword>
  <keyword>biomechanics</keyword>
  <keyword>treatment</keyword>
  <keyword>symptoms</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/NCT02234895
org study id: H14-01313
nct id: NCT02234895
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of
      life and increased economic burden. Current research has focused on expensive, invasive
      treatments, whereas inexpensive conservative treatments have received less attention. One
      such treatment is the use of orthotics to reduce pain and increase function in people with
      knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and
      contradictory, and could benefit from more research taking into account foot posture. This
      study aims to compare the use of two orthotics designs in people with knee OA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in knee joint load during walking: knee adduction moment
time frame: Baseline and 2 months
description: Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.
The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
measure: Change in Knee Pain
time frame: Baseline and 2 Months
description: The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
measure: Change in Self-Reported Physical Function
time frame: Baseline and 2 Months
description: The physical function subscale (17 questions) on the WOMAC will be used.
measure: Change in Foot Pain
time frame: Baseline and 2 Months
description: Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies
measure: Participant perceived response to treatment
time frame: 2 Months
description: At follow-up for each orthotic, participants will rate overall perceived change in pain and physical function (vs. baseline) on an ordinal scale (1-much worse, 2-slightly worse, 3-same, 4-slightly better, 5-much better). This will be dichotomized into 'improvement' (4 and 5) or 'no improvement'
arm group label: Lateral wedge plus medial arch support
arm group type: Experimental
description: The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.
arm group label: Lateral wedge
arm group type: Experimental
description: The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance.
intervention type: Device
intervention name: Lateral wedge
description: This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
arm group label: Lateral wedge
intervention type: Device
intervention name: Lateral wedge plus medial arch support
description: This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
arm group label: Lateral wedge plus medial arch support
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael A Hunt, PhD, PT
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee