<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/NCT02231567</url>
  </required_header>
  <id_info>
    <org_study_id>3298/2014</org_study_id>
    <nct_id>NCT02231567</nct_id>
  </id_info>
  <brief_title>Neurocognitive Rehabilitation After Hip Replacement</brief_title>
  <official_title>Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effectiveness of an approach based on&#xD;
      neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution&#xD;
      involves the use of higher cognitive functions (attention, memory, language), not required in&#xD;
      a traditional approach proprioceptive, in order to obtain a more complete and long-lasting&#xD;
      recovery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of WOMAC Questionnaire from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Barthel Index from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>Index for the evaluation of patient's performance in activities of daily living. The index is divided into eleven sub-categories that assess activities of daily living (ability to feed themselves, to ensure personal hygiene and dressing) and the mobility of the individual (gait, postural changes and transfers, stairs). For each item is assigned a score variable from full to reduced or absent functionality. The questionnaire is administered by an examiner and is based on a metric scale ranging from 0 (total dependence) to 100 (minimum dependence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Visual Analogue Scale (VAS) from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>It is based on a ten point scale, where 0 means no pain and 10 means the greatest pain ever. It enables the patients to express their pain intensity as numerical value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>Assessment of health status using the SF-36 Health Survey Questionnaire. The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional problems, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). Indices are derived from 8 subcategories evaluated and allow to summarize the results. The questionnaire is self-administered and subcategories is that the indices are based on a metric scale ranging from 0 (worst health status) to 100 (best health status) 17, 18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>Questionnaire for the assessment of psychological well-being and positive functioning of the individual. It includes 84 items and measures the six dimensions /scales of well-being proposed in the model developed by the American psychologist Carol Ryff: self-acceptance, positive interpersonal relationships, autonomy, environmental control, personal growth and purpose in life. The questionnaire is self-administered and each item is evaluated by a metric scale ranging from 1 (disagree) to 6 (totally agree). The negatively worded items are counted in reverse order. The sum score for each scale is calculated by summing the degree of agreement of each item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parameters of Gait Analysis from baseline to 24 weeks</measure>
    <time_frame>baseline, 1 week, 8 weeks, 16 weeks, 24 weeks</time_frame>
    <description>It's used to define the pattern of gait. The Gait Analysis provides different types of information such as quantitative kinematics data (angles of flexion-extension, abduction-adduction and external rotation of the main joints), velocity data (moments and powers the major joints) and electromyographic data.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Neurocognitive Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is a rehabilitative approach based on exercises for the recovery of hip's range of motion, muscle strengthening exercises, stretching exercises of the hamstring muscles, adductor and iliopsoas and proprioceptive exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurocognitive Rehabilitation</intervention_name>
    <description>The patients will be treated in inpatient clinic with a neurocognitive rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.</description>
    <arm_group_label>Neurocognitive Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Rehabilitation</intervention_name>
    <description>The patients will be treated in inpatient clinic with a traditional rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.</description>
    <arm_group_label>Traditional Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical&#xD;
             replacement with a posterior-lateral approach and the use of a non-cemented prosthesis&#xD;
             (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a&#xD;
             ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Different diagnosis from hip osteoarthritis (eg. Fracture)&#xD;
&#xD;
          -  Concomitant osteoarthrosis of the hip or knee with gait restrictions&#xD;
&#xD;
          -  Lameness for more than six months&#xD;
&#xD;
          -  Central nervous system or Peripheral nervous system disorders&#xD;
&#xD;
          -  Systemic inflammatory disorders (eg. Rheumatoid Arthritis)&#xD;
&#xD;
          -  Systemic infectious disorders&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Neoplastic disorders&#xD;
&#xD;
          -  Surgical revisions&#xD;
&#xD;
          -  Intraoperative complications&#xD;
&#xD;
          -  Suspected hip replacement infection&#xD;
&#xD;
          -  Hip replacement with endoprosthesis.&#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>Vincenzo Maria Saraceni</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umberto I Hospital, Sapienza University of Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umberto I Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Teresa Paolucci</investigator_full_name>
    <investigator_title>medical director</investigator_title>
  </responsible_party>
  <keyword>hip replacement</keyword>
  <keyword>neurocognitive rehabilitation</keyword>
  <keyword>WOMAC questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT02231567
org study id: 3298/2014
nct id: NCT02231567
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the effectiveness of an approach based on
      neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution
      involves the use of higher cognitive functions (attention, memory, language), not required in
      a traditional approach proprioceptive, in order to obtain a more complete and long-lasting
      recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change of WOMAC Questionnaire from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).
measure: Change of Barthel Index from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: Index for the evaluation of patient's performance in activities of daily living. The index is divided into eleven sub-categories that assess activities of daily living (ability to feed themselves, to ensure personal hygiene and dressing) and the mobility of the individual (gait, postural changes and transfers, stairs). For each item is assigned a score variable from full to reduced or absent functionality. The questionnaire is administered by an examiner and is based on a metric scale ranging from 0 (total dependence) to 100 (minimum dependence).
measure: Change of Visual Analogue Scale (VAS) from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: It is based on a ten point scale, where 0 means no pain and 10 means the greatest pain ever. It enables the patients to express their pain intensity as numerical value.
measure: Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: Assessment of health status using the SF-36 Health Survey Questionnaire. The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional problems, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). Indices are derived from 8 subcategories evaluated and allow to summarize the results. The questionnaire is self-administered and subcategories is that the indices are based on a metric scale ranging from 0 (worst health status) to 100 (best health status) 17, 18.
measure: Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: Questionnaire for the assessment of psychological well-being and positive functioning of the individual. It includes 84 items and measures the six dimensions /scales of well-being proposed in the model developed by the American psychologist Carol Ryff: self-acceptance, positive interpersonal relationships, autonomy, environmental control, personal growth and purpose in life. The questionnaire is self-administered and each item is evaluated by a metric scale ranging from 1 (disagree) to 6 (totally agree). The negatively worded items are counted in reverse order. The sum score for each scale is calculated by summing the degree of agreement of each item.
measure: Change of parameters of Gait Analysis from baseline to 24 weeks
time frame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
description: It's used to define the pattern of gait. The Gait Analysis provides different types of information such as quantitative kinematics data (angles of flexion-extension, abduction-adduction and external rotation of the main joints), velocity data (moments and powers the major joints) and electromyographic data.
arm group label: Neurocognitive Rehabilitation
arm group type: Experimental
description: Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).
arm group label: Traditional Rehabilitation
arm group type: Active Comparator
description: It is a rehabilitative approach based on exercises for the recovery of hip's range of motion, muscle strengthening exercises, stretching exercises of the hamstring muscles, adductor and iliopsoas and proprioceptive exercises.
intervention type: Other
intervention name: Neurocognitive Rehabilitation
description: The patients will be treated in inpatient clinic with a neurocognitive rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
arm group label: Neurocognitive Rehabilitation
intervention type: Other
intervention name: Traditional Rehabilitation
description: The patients will be treated in inpatient clinic with a traditional rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
arm group label: Traditional Rehabilitation
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vincenzo Maria Saraceni
role: Principal Investigator
affiliation: Umberto I Hospital, Sapienza University of Rome
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Teresa Paolucci
investigator title: medical director
mesh term: Osteoarthritis, Hip