<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/NCT03783806</url>
  </required_header>
  <id_info>
    <org_study_id>PCHOAI</org_study_id>
    <nct_id>NCT03783806</nct_id>
  </id_info>
  <brief_title>Postural Control in Degenerative and Inflammatory Diseases of the Hip</brief_title>
  <acronym>PCHOAI</acronym>
  <official_title>Postural Control in Degenerative and Inflammatory Diseases of the Hip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</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>
      Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip&#xD;
      disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of&#xD;
      our study is to determine the postural control in patients suffering from OA and RA of the&#xD;
      hip joint during different conditions, i.e., on both stable and compliant surfaces with&#xD;
      opened or closed eyes to determine the possible differences between these two diseases in&#xD;
      this respect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Determination of functional status, using the following outcome measures: Harris Hip Score,&#xD;
      the Functional status of the hip joint is rated with the Harris Hip Score (HHS), Visual&#xD;
      Analogue Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up &amp; Go&#xD;
      test.&#xD;
&#xD;
      Posturography measurements, Postural control tests&#xD;
&#xD;
      The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test&#xD;
      how people adapt to changing sensory conditions during the maintenance of stance. We used the&#xD;
      modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the&#xD;
      body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured&#xD;
      during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a&#xD;
      quiet room. Signals were amplified and sampled at 16 Hz via an analogue-to-digital converter.&#xD;
      Subjects stood barefoot on the platform, with the feet positioned side by side and arms&#xD;
      hanging freely at their side. Toe-out was positioned to subjects' comfort. The CoP excursions&#xD;
      along antero-posterior (AP) and medio-lateral (ML) axes were performed both on firm (the&#xD;
      stable surface of the platform) and foam surfaces [an Airex Balance Pad (dimensions: 50 cm&#xD;
      length x 41 cm width x 6 cm height) placed on the platform], always starting with standing on&#xD;
      the stable surface. In each condition, subjects had to stand first with the eyes open (EO),&#xD;
      when subjects had to look at a target fixed at eye level at a distance of approximately 1 m,&#xD;
      and then measurements were also performed with closed eyes (EC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Harris Hip Score (HHS)</measure>
    <time_frame>1 hour</time_frame>
    <description>The score has a maximum at 100 points (best possible function), covering pain (part I, 1 item, 0-44 points), function and activities (part II, 7 items, 0-47 points) and range of motion and absence of deformity (part III, 3 items, 0-9 points). [Grading: &lt;70 poor, 70-79 fair, 80-89 good, 90-100 excellent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>1 hour</time_frame>
    <description>Hip pain (average pain on movement over the previous 72 hours) is assessed by using a Visual Analogue Scale (VAS) (the range of the scale: 0-100 mm; where the subjects subjectively judge the actual level of pain between the minimum and maximum range. The meaning of the end-points: minimum: no pain- maximum: unbearable pain). The lower values represent better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
    <time_frame>1 hour</time_frame>
    <description>The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain (WOMAC A, 5 items), joint stiffness (WOMAC B, 2 items) and disability (WOMAC C, 17 items) by using visual analogue scales. Lower scores indicated less pain, less stiffness or less disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up &amp; Go test</measure>
    <time_frame>1 hour</time_frame>
    <description>To assess the functional mobility of the subjects, we applied the Timed Up &amp; Go (TUG) test. During the testing procedure, subjects were timed (recorded in seconds) for standing up from a chair (45 cm), walking 3 m, passing around an object and then returning to sitting position in the chair. The subjects were instructed to walk as quickly as possible but not to run. The subjects had three trials with 1 min pause between each trial; the trials were recorded in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Posturography measurements</measure>
    <time_frame>1 hour</time_frame>
    <description>The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <condition>Hip Arthritis</condition>
  <arm_group>
    <arm_group_label>Osteoarthrosis (OA)</arm_group_label>
    <description>Patients with primary osteoarthrosis, waiting for a total hip replacement. Determination of functional status, posturography measurements, postural tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis (RA)</arm_group_label>
    <description>Patients with rheumatoid arthritis affecting hip joint. Determination of functional status, posturography measurements, postural tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (C)</arm_group_label>
    <description>The healthy reference group was matched with the patient groups for age, gender and body mass index (BMI). Determination of functional status, posturography measurements, postural tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Posturography measurements</intervention_name>
    <description>Determination of functional status, Posturography measurements, postural tests</description>
    <arm_group_label>Control (C)</arm_group_label>
    <arm_group_label>Osteoarthrosis (OA)</arm_group_label>
    <arm_group_label>Rheumatoid arthritis (RA)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary hip osteoarthritis (OA group), patients with inflammatory hip disease&#xD;
        (RA group) and healthy subjects (control group) are enrolled in the study. All subjects&#xD;
        were independent and capable of self-care and daily household tasks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  C-reactive protein and Westergreen values had to be under the upper level of the&#xD;
             normal values.&#xD;
&#xD;
          -  Patients should have unilateral hip pain on most of the days for several months&#xD;
&#xD;
          -  Controls should have no hip pain or functional impairment in the hip joint or any&#xD;
             other joint of the lower extremities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of trauma to the hip joint or in the pelvic region,&#xD;
&#xD;
          -  previous hip fracture or hip surgery,&#xD;
&#xD;
          -  hip joint infection and congenital or developmental diseases&#xD;
&#xD;
          -  any complaints in the other joints of the lower limbs&#xD;
&#xD;
          -  any disease that could worsen their physical or balance parameters&#xD;
&#xD;
          -  cancer,&#xD;
&#xD;
          -  endocrine,&#xD;
&#xD;
          -  cerebrovascular disease,&#xD;
&#xD;
          -  Parkinson's syndrome,&#xD;
&#xD;
          -  epilepsy,&#xD;
&#xD;
          -  polyneuropathy,&#xD;
&#xD;
          -  neuromuscular disorder,&#xD;
&#xD;
          -  cardiovascular disease without medication,&#xD;
&#xD;
          -  atherosclerosis of the lower extremities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Edit Nagy, PhD</last_name>
    <phone>+36703824421</phone>
    <email>editsnagy@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Regina Finta</last_name>
    <phone>+36708844435</phone>
    <email>fintaregina@etszk.u-szeged.hu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Szeged, Faculty of Health and Social Studies, Department of Physiotherapy</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6726</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edit Nagy, PhD</last_name>
      <phone>+36703824421</phone>
      <email>editsnagy@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Szeged University</investigator_affiliation>
    <investigator_full_name>Edit Nagy</investigator_full_name>
    <investigator_title>PhD, Head of Unit</investigator_title>
  </responsible_party>
  <keyword>hip, postural control, degenerative, inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT03783806
org study id: PCHOAI
nct id: NCT03783806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with primary hip osteoarthritis (OA group) and patients with inflammatory hip
      disease (RA group) and healthy subjects (control group) are enrolled in the study. The aim of
      our study is to determine the postural control in patients suffering from OA and RA of the
      hip joint during different conditions, i.e., on both stable and compliant surfaces with
      opened or closed eyes to determine the possible differences between these two diseases in
      this respect.
Determination of functional status, using the following outcome measures: Harris Hip Score,
      the Functional status of the hip joint is rated with the Harris Hip Score (HHS), Visual
      Analogue Scale, Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up & Go
      test.

      Posturography measurements, Postural control tests

      The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test
      how people adapt to changing sensory conditions during the maintenance of stance. We used the
      modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the
      body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured
      during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a
      quiet room. Signals were amplified and sampled at 16 Hz via an analogue-to-digital converter.
      Subjects stood barefoot on the platform, with the feet positioned side by side and arms
      hanging freely at their side. Toe-out was positioned to subjects' comfort. The CoP excursions
      along antero-posterior (AP) and medio-lateral (ML) axes were performed both on firm (the
      stable surface of the platform) and foam surfaces [an Airex Balance Pad (dimensions: 50 cm
      length x 41 cm width x 6 cm height) placed on the platform], always starting with standing on
      the stable surface. In each condition, subjects had to stand first with the eyes open (EO),
      when subjects had to look at a target fixed at eye level at a distance of approximately 1 m,
      and then measurements were also performed with closed eyes (EC).
observational model: Case-Control
time perspective: Cross-Sectional
measure: Harris Hip Score (HHS)
time frame: 1 hour
description: The score has a maximum at 100 points (best possible function), covering pain (part I, 1 item, 0-44 points), function and activities (part II, 7 items, 0-47 points) and range of motion and absence of deformity (part III, 3 items, 0-9 points). [Grading: <70 poor, 70-79 fair, 80-89 good, 90-100 excellent
measure: Visual Analogue Scale
time frame: 1 hour
description: Hip pain (average pain on movement over the previous 72 hours) is assessed by using a Visual Analogue Scale (VAS) (the range of the scale: 0-100 mm; where the subjects subjectively judge the actual level of pain between the minimum and maximum range. The meaning of the end-points: minimum: no pain- maximum: unbearable pain). The lower values represent better outcome.
measure: Western Ontario and McMaster Universities Osteoarthritis Index
time frame: 1 hour
description: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain (WOMAC A, 5 items), joint stiffness (WOMAC B, 2 items) and disability (WOMAC C, 17 items) by using visual analogue scales. Lower scores indicated less pain, less stiffness or less disability.
measure: Timed Up & Go test
time frame: 1 hour
description: To assess the functional mobility of the subjects, we applied the Timed Up & Go (TUG) test. During the testing procedure, subjects were timed (recorded in seconds) for standing up from a chair (45 cm), walking 3 m, passing around an object and then returning to sitting position in the chair. The subjects were instructed to walk as quickly as possible but not to run. The subjects had three trials with 1 min pause between each trial; the trials were recorded in seconds.
measure: Posturography measurements
time frame: 1 hour
description: The Clinical Test of Sensory Interaction on Balance (CTSIB) uses different conditions to test how people adapt to changing sensory conditions during the maintenance of stance. We used the modified CTSIB by NeuroCom to perform the test on a computerized force plate to measure the body sway. Static postural stability [displacement of Centre of Pressure (CoP)] was measured during standing on a single force platform (Stabilometer, ZWE-PII) for 20-s periods in a quiet room.
arm group label: Osteoarthrosis (OA)
description: Patients with primary osteoarthrosis, waiting for a total hip replacement. Determination of functional status, posturography measurements, postural tests.
arm group label: Rheumatoid arthritis (RA)
description: Patients with rheumatoid arthritis affecting hip joint. Determination of functional status, posturography measurements, postural tests.
arm group label: Control (C)
description: The healthy reference group was matched with the patient groups for age, gender and body mass index (BMI). Determination of functional status, posturography measurements, postural tests.
intervention type: Diagnostic Test
intervention name: Posturography measurements
description: Determination of functional status, Posturography measurements, postural tests
arm group label: Control (C)
arm group label: Osteoarthrosis (OA)
arm group label: Rheumatoid arthritis (RA)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edit Nagy, PhD
phone: +36703824421
email: editsnagy@gmail.com
last name: Regina Finta
phone: +36708844435
email: fintaregina@etszk.u-szeged.hu
facility: 
status: Recruiting
contact: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Szeged University
investigator full name: Edit Nagy
investigator title: PhD, Head of Unit
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided