<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/NCT02995668</url>
  </required_header>
  <id_info>
    <org_study_id>PRE_ATR_BALANCE</org_study_id>
    <nct_id>NCT02995668</nct_id>
  </id_info>
  <brief_title>Effects of Specific Balance Training Prior TKR Surgery in the Early Postoperative Outcomes</brief_title>
  <acronym>PRE_TKR_BLC</acronym>
  <official_title>Influencia de un Entrenamiento Preoperatorio de propiocepción y Equilibrio en Pacientes Con Artrosis Severa de Rodilla en Espera Para la intervención de Artroplastia Total</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Clínico Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knee osteoarthritis is one of the most common pathologies in old people, and the leading&#xD;
      cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility,&#xD;
      functional impairment and proprioceptive deficit. When conservative treatments fail to&#xD;
      control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly&#xD;
      because of its efficacy on pain relief. In recent decades, this surgical procedure has been&#xD;
      soared, and it has also aroused the interest of researches about the patients' outcomes after&#xD;
      surgery.&#xD;
&#xD;
      Despite the TKR results in good reported outcomes, after surgery patients may manifest&#xD;
      persistent pain and problems affecting to their functionality, stability, walking speed,&#xD;
      proprioception, motor control, risk of falling and therefore to their quality of life. In&#xD;
      more than a third of the cases, those deficiencies may be extended after surgery from six&#xD;
      months to one year, when subjects use to achieve the plateau functional values.&#xD;
&#xD;
      Traditional rehabilitation programs have been usually focused on improving muscle strength of&#xD;
      the lower limbs as well as the functionality with specific exercises to achieve this purpose,&#xD;
      and to a lesser extent on balance and proprioception exercises. Evidence supports this&#xD;
      approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the&#xD;
      most important factors for a complete rehabilitation, since benefits of proprioceptive and&#xD;
      balance trainings may range from better stability and motor control, improvements in both&#xD;
      static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that&#xD;
      the combination of traditional functional rehabilitation together with balance training may&#xD;
      help to restore functional deficits to a larger extent than usual therapy, and based on a&#xD;
      systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016),&#xD;
      sensori-motor training is an acceptable adjust to usual physiotherapy care .&#xD;
&#xD;
      Looking into the effect of preoperative trainings or education before TKR surgery, it is&#xD;
      aimed at improving the physical function, but also managing the expectations of the surgery&#xD;
      for a better recovery. There is from low to moderate evidence about the effects of TKR&#xD;
      pre-interventional training programs, and some authors have argued that the effects are too&#xD;
      small to be consider clinically relevant.&#xD;
&#xD;
      In general, the preoperative program is usually focused on functional and strengthening&#xD;
      exercises. Despite of proprioception is used in the clinical practice for the prevention and&#xD;
      recovery of many orthopedics injuries, the amount of evidence about the effects of&#xD;
      proprioceptive training programs for knee and hip replacement is not large, few works&#xD;
      compares pre-habilitation and post-rehabilitation programs, and there is not systematically&#xD;
      reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional&#xD;
      training programs.&#xD;
&#xD;
      In this framework, this aimed at evaluating the effects of specific-task oriented&#xD;
      proprioceptive and balance training programs when conducted by patients undergoing TKR before&#xD;
      and after surgery, and will compare these effects to the outcomes achieved with traditional&#xD;
      strength-functional programs, as well as to no specific prehabilitation training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 18, 2018</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>http://www.koos.nu/KOOSusersguide2012.pdf</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>Overall state of balance. Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test (TUG)</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Range of Mobility (ROM)</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>Knee Range of Mobility (Flexion, Extension) in degrees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps Strength</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>Electronic dynamometer in Newton</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro Quality of Life 5 Dimension (Euro-QoL-5D)</measure>
    <time_frame>change from baseline to the week before surgery, 2 and 6 weeks after surgery</time_frame>
    <description>Quality of Life assessment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-active comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strength-Function</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balance-Proprioception</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength-Function</intervention_name>
    <description>Preoperative functional and strength capabilities training.</description>
    <arm_group_label>Balance-Proprioception</arm_group_label>
    <arm_group_label>Strength-Function</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance-Proprioception</intervention_name>
    <description>Preoperative proprioceptive and balance capabilities training</description>
    <arm_group_label>Balance-Proprioception</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 60 and 80.&#xD;
&#xD;
          -  Subjects with severe knee osteoarthritis that have not been operated before.&#xD;
&#xD;
          -  Patients will be operated with the same total replacement prosthesis and same surgical&#xD;
             procedure.&#xD;
&#xD;
          -  The score in Berg scale must be greater than 21, indicating a medium-low risk of&#xD;
             falling.&#xD;
&#xD;
          -  The score of the Mini-Mental State Examination must be equal or greater than 20, which&#xD;
             means they do not have moderate or severe cognitive impairment.&#xD;
&#xD;
          -  Once the informed consent is read and explained, patients must accept and agree to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with morphological alterations hip or ankle (also knee).&#xD;
&#xD;
          -  Patient with suspected deep vein thrombosis or post-surgical infection of the operated&#xD;
             knee.&#xD;
&#xD;
          -  Patient with pathology of central origin (i.e. cerebellar) that could interfere with&#xD;
             the results of the test of balance or strength&#xD;
&#xD;
          -  Patient with vestibular pathology that could interfere with the results of the test of&#xD;
             balance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose M Blasco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Jose María Blasco Igual</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT02995668
org study id: PRE_ATR_BALANCE
nct id: NCT02995668
lead sponsor: 
collaborator: 
has dmc: Yes
Knee osteoarthritis is one of the most common pathologies in old people, and the leading
      cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility,
      functional impairment and proprioceptive deficit. When conservative treatments fail to
      control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly
      because of its efficacy on pain relief. In recent decades, this surgical procedure has been
      soared, and it has also aroused the interest of researches about the patients' outcomes after
      surgery.

      Despite the TKR results in good reported outcomes, after surgery patients may manifest
      persistent pain and problems affecting to their functionality, stability, walking speed,
      proprioception, motor control, risk of falling and therefore to their quality of life. In
      more than a third of the cases, those deficiencies may be extended after surgery from six
      months to one year, when subjects use to achieve the plateau functional values.

      Traditional rehabilitation programs have been usually focused on improving muscle strength of
      the lower limbs as well as the functionality with specific exercises to achieve this purpose,
      and to a lesser extent on balance and proprioception exercises. Evidence supports this
      approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the
      most important factors for a complete rehabilitation, since benefits of proprioceptive and
      balance trainings may range from better stability and motor control, improvements in both
      static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that
      the combination of traditional functional rehabilitation together with balance training may
      help to restore functional deficits to a larger extent than usual therapy, and based on a
      systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016),
      sensori-motor training is an acceptable adjust to usual physiotherapy care .

      Looking into the effect of preoperative trainings or education before TKR surgery, it is
      aimed at improving the physical function, but also managing the expectations of the surgery
      for a better recovery. There is from low to moderate evidence about the effects of TKR
      pre-interventional training programs, and some authors have argued that the effects are too
      small to be consider clinically relevant.

      In general, the preoperative program is usually focused on functional and strengthening
      exercises. Despite of proprioception is used in the clinical practice for the prevention and
      recovery of many orthopedics injuries, the amount of evidence about the effects of
      proprioceptive training programs for knee and hip replacement is not large, few works
      compares pre-habilitation and post-rehabilitation programs, and there is not systematically
      reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional
      training programs.

      In this framework, this aimed at evaluating the effects of specific-task oriented
      proprioceptive and balance training programs when conducted by patients undergoing TKR before
      and after surgery, and will compare these effects to the outcomes achieved with traditional
      strength-functional programs, as well as to no specific prehabilitation training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: http://www.koos.nu/KOOSusersguide2012.pdf
measure: Berg Balance Scale (BBS)
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: Overall state of balance. Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test
measure: Timed Up and Go Test (TUG)
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds
measure: Knee Range of Mobility (ROM)
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: Knee Range of Mobility (Flexion, Extension) in degrees
measure: Quadriceps Strength
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: Electronic dynamometer in Newton
measure: Euro Quality of Life 5 Dimension (Euro-QoL-5D)
time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
description: Quality of Life assessment
arm group label: Control
arm group type: No Intervention
description: Non-active comparator
arm group label: Strength-Function
arm group type: Active Comparator
description: Active comparator
arm group label: Balance-Proprioception
arm group type: Experimental
description: Experimental
intervention type: Other
intervention name: Strength-Function
description: Preoperative functional and strength capabilities training.
arm group label: Balance-Proprioception
arm group label: Strength-Function
intervention type: Other
intervention name: Balance-Proprioception
description: Preoperative proprioceptive and balance capabilities training
arm group label: Balance-Proprioception
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jose M Blasco, PhD
role: Principal Investigator
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Jose María Blasco Igual
investigator title: PhD
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No