<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/NCT03837041</url>
  </required_header>
  <id_info>
    <org_study_id>12/17</org_study_id>
    <nct_id>NCT03837041</nct_id>
  </id_info>
  <brief_title>Evaluation of Proprioception</brief_title>
  <acronym>PROPRIO_TPG</acronym>
  <official_title>Evaluate the Proprioception in Patients With Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The osteoarthritis (OA) is a chronic and degenerative disease which brings articular&#xD;
      cartilage degeneration. As a consequence, balance and proprioception could be dangerously&#xD;
      reduced after total knee arthroplasty.&#xD;
&#xD;
      Several studies demonstrated the correlation between OA, proprioception reduction and&#xD;
      increased risk of falling. The aim of this study is to evaluate the proprioception&#xD;
      improvement in patients with total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of a proprioception</measure>
    <time_frame>24 months</time_frame>
    <description>Stability Index (SI) in percentage the maximum is 100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of performance in lower limb questionnaire</measure>
    <time_frame>24 months</time_frame>
    <description>Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KSS Score</measure>
    <time_frame>24 months</time_frame>
    <description>The score range from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical score</measure>
    <time_frame>24 months</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index the WOMAC evaluates 3 dimensions: pain, stiffness, and physical function with 5, 2, and 17 questions, respectively. The Likert version of the WOMAC is rated on an ordinal scale of 0 to 4, with lower scores indicating lower levels of symptoms or physical disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Proprioceptive Disorders</condition>
  <arm_group>
    <arm_group_label>Reconditioning Proprioception group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training Proprioception 1 hour for 2 day a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reconditioning Proprioception</intervention_name>
    <description>Proprioceptive training using Delos Postural Proprioceptive System</description>
    <arm_group_label>Reconditioning Proprioception group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria are patients with ASA: 1, 2 or 3; patients who have given their informed&#xD;
        written consent to participate in the study; patients live in Bologna and neighboring&#xD;
        areas.&#xD;
&#xD;
        Exclusion Criteria are patients with previous osteotomy of the lower limbs; patients with&#xD;
        post-traumatic arthrosis; patients with severe preoperative valgus deformity (Hip Knee&#xD;
        Ankle angle&gt; 10 °); patients with BMI&gt; 40 kg / m2; patients with rheumatoid arthritis;&#xD;
        patients with chronic inflammatory joint diseases; patients with walking diseases&#xD;
        (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe&#xD;
        arthrosis of the ankle (Kellgren-Lawrence&gt; 3); patients with Severe coxarthrosis&#xD;
        (Kellgren-Lawrence&gt; 3); patients with severe postural instability; patients with cognitive&#xD;
        impairments, patients with concomitant neurological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
    <investigator_full_name>Stefano Zaffagnini</investigator_full_name>
    <investigator_title>Full Professor and Head of department</investigator_title>
  </responsible_party>
  <keyword>total knee arthroplasty</keyword>
  <keyword>Proprioception</keyword>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Somatosensory Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03837041
org study id: 12/17
nct id: NCT03837041
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The osteoarthritis (OA) is a chronic and degenerative disease which brings articular
      cartilage degeneration. As a consequence, balance and proprioception could be dangerously
      reduced after total knee arthroplasty.

      Several studies demonstrated the correlation between OA, proprioception reduction and
      increased risk of falling. The aim of this study is to evaluate the proprioception
      improvement in patients with total knee arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Improvement of a proprioception
time frame: 24 months
description: Stability Index (SI) in percentage the maximum is 100%
measure: Evaluation of performance in lower limb questionnaire
time frame: 24 months
description: Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)
measure: KSS Score
time frame: 24 months
description: The score range from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
measure: Clinical score
time frame: 24 months
description: Western Ontario and McMaster Universities Osteoarthritis Index the WOMAC evaluates 3 dimensions: pain, stiffness, and physical function with 5, 2, and 17 questions, respectively. The Likert version of the WOMAC is rated on an ordinal scale of 0 to 4, with lower scores indicating lower levels of symptoms or physical disability.
arm group label: Reconditioning Proprioception group
arm group type: Active Comparator
description: Training Proprioception 1 hour for 2 day a week
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: Reconditioning Proprioception
description: Proprioceptive training using Delos Postural Proprioceptive System
arm group label: Reconditioning Proprioception group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Ortopedico Rizzoli
investigator full name: Stefano Zaffagnini
investigator title: Full Professor and Head of department
mesh term: Somatosensory Disorders
sharing ipd: Undecided