xml: <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/NCT06012032</url>
    </required_header>
    <id_info>
      <org_study_id>4381</org_study_id>
      <nct_id>NCT06012032</nct_id>
    </id_info>
    <brief_title>Application of BHOHB SPINAL-METER and CervicalMeter for Posture Assessment</brief_title>
    <acronym>BHOHB</acronym>
    <official_title>Application in Rehabilitation of BHOHB SPINAL-METER and CervicalMeter for the Assessment of Posture in Patients With Dysmorphisms and Paramorphisms of the Spine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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 postural observation of the patient has an important role for the evaluation and&#xD;
        monitoring of orthopedic and neurological degenerative pathologies. The study of the effects&#xD;
        of rehabilitation in the treatment of postural alterations depends on the validity,&#xD;
        sensitivity and specificity of the tool used.&#xD;
  &#xD;
        The radiographic evaluation of the spine in the standard anteroposterior and lateral&#xD;
        projections is the gold standard and provides a standardized and objective measure of the&#xD;
        dysmorphisms and paramorphisms of the spine, although it requires exposure to X-rays and with&#xD;
        costs of the method especially in the need to repeat the radiological examination in time.&#xD;
  &#xD;
        Non-radiological tools for postural assessment have been proposed in the literature, with&#xD;
        uncertain judgments by the various authors regarding their validity and reliability, due to&#xD;
        the heterogeneity and poor quality of the studies in this regard.&#xD;
  &#xD;
        The aim of this study is to evaluate the effectiveness of a new posture analysis methodology&#xD;
        (BHOHB SPINAL-METER ® and CervicalMeter®) in measuring spine dysmorphisms and paramorphisms&#xD;
        in adult patients affected by orthopedic and neurological degenerative pathologies, who carry&#xD;
        out rehabilitation at the Policlinico Gemelli Foundation (FPG) Hospitalization and&#xD;
        Rehabilitation Services clinic. In particular, the correspondence of radiological and&#xD;
        clinical data with the reports obtained from the &quot;BHOHB SPINAL-METER ® and CervicalMeter®&quot;&#xD;
        will be considered and the relationship between the data obtained with the two methods and&#xD;
        the characteristics of pain, disability, balance and quality of life will be observed of&#xD;
        patients suffering from orthopedic and neurological disease with dysmorphisms and&#xD;
        paramorphisms of the spine, belonging to the rehabilitation clinic who agree to participate&#xD;
        in the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Setting: outpatients ward, UOSA( &quot;Unità operativa semplice ambulatoriale&quot; simple outpatient&#xD;
        operating unit) Rehabilitation Service Hospitalization and FPG Rehabilitation Services.&#xD;
  &#xD;
        Duration of the study: 1 year&#xD;
  &#xD;
        Goals:&#xD;
  &#xD;
        Primary endpoint: evaluation of the correlation of radiological and clinical reports with&#xD;
        those obtained from the device under study; in particular, the measurement of the&#xD;
        radiological Cobb angle (from standard X-ray in orthostatism, on a single plate in the&#xD;
        anteroposterior projection) of the patient will be correlated with that evaluated with the&#xD;
        BHOHB SPINAL-METER® and CervicalMeter® Secondary end point: evaluation of the effects of&#xD;
        postural alteration measured radiologically and with the &quot;BHOHB SPINAL-METER ® and&#xD;
        CervicalMeter®&quot; on static and dynamic balance, on spine pain and on the quality of life of&#xD;
        patients, evaluated respectively with the measures Berg Balance scale, Tinetti Gait&#xD;
        Evaluation, NRS (Numeric rating Scale) and with stabilometric examination, which are&#xD;
        performed routinely in outpatient visits.&#xD;
  &#xD;
        Calculation of the sample size: Based on the current literature on the results obtained via&#xD;
        RX and on the data of the new instrument held by the investigators, in order to estimate a&#xD;
        Pearson correlation coefficient equal to 0.90, with a width of the interval of 0.10 and a&#xD;
        bilateral confidence interval of 95%, it is considered necessary to enroll a minimum number&#xD;
        of patients equal to 62.&#xD;
  &#xD;
        Statistical analysis: Qualitative variables will be described through absolute frequencies&#xD;
        and percentages, while quantitative variables as mean and standard deviation or median and&#xD;
        interquartile range according to their distribution, which will be tested through the&#xD;
        Shapiro-Wilk test.&#xD;
  &#xD;
        The evaluation of the degree of correlation between the measurement of the radiological Cobb&#xD;
        angle of the patient with that evaluated with the BHOHB SPINAL-METER ® and CervicalMeter®&#xD;
        will be performed by calculating the Pearson correlation coefficient, and further exemplified&#xD;
        by suitable scatter plots.&#xD;
  &#xD;
        The effects of postural alteration measured radiologically and with the BHOHB SPINAL-METER ®&#xD;
        and CervicalMeter®, on static and dynamic balance, spine pain and patients' quality of life&#xD;
        will be analyzed through univariate and multivariate linear regression models.&#xD;
  &#xD;
        A p-value &lt;0.05 will be considered statistically significant. The statistical analyzes will&#xD;
        be performed using the STATA 16 software.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 17, 2022</start_date>
    <completion_date type="Anticipated">February 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 17, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cobb angle</measure>
      <time_frame>This is a baseline evaluation. The study does not include further evaluations. We aimed to perform a one-time comparison of the Cobb's angle measured through BHOHB SPINAL-METER versus standard spinal radiography</time_frame>
      <description>radiographic angle measuring the degree of scoliosis in the frontal plane</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Berg Balance scale</measure>
      <time_frame>This is a baseline evaluation. The study does not include further evaluations. The Berg balance scale score goes from 0 to 56 points. Higher scores indicate low/no balance deficit and low/no risk of falling.</time_frame>
      <description>balance scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinetti scale</measure>
      <time_frame>This is a baseline evaluation. The study does not include further evaluations. The Tinetti scale score goes from 0 to 26. The higher scores indicate a lower risk of falls</time_frame>
      <description>balance and deambulation scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS numeric rating scale for pain</measure>
      <time_frame>This is a baseline evaluation. The study does not include further evaluations. NRS score goes from 0 to 10. Higher scores correspond to worse pain perception.</time_frame>
      <description>visual analogical scale for pain assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>stabilometric test</measure>
      <time_frame>This is a baseline evaluation. The study does not include further evaluations.</time_frame>
      <description>assessment of static balance</description>
    </secondary_outcome>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Osteoporosis</condition>
    <condition>Scoliosis</condition>
    <condition>Postural; Defect</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients affected by dysmorphisms and paramorphisms of the spine due to degenerative&#xD;
          orthopedic and neurological pathologies, who undergo rehabilitation at the FPG&#xD;
          Hospitalization and Rehabilitation Services clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged &gt; 18 years&#xD;
  &#xD;
            -  MMSE &gt;23&#xD;
  &#xD;
            -  Subjects affected by orthopedic and neurological degenerative pathologies and with&#xD;
               dysmorphisms or paramorphisms of the spine, capable of maintaining an upright position&#xD;
               and ambulating without aids.&#xD;
  &#xD;
            -  Signature of the informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychiatric pathologies,&#xD;
  &#xD;
            -  Cognitive impairment (MMSE&lt;23),&#xD;
  &#xD;
            -  Inability to stand and walk.&#xD;
  &#xD;
            -  Failure to sign the informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>gianpaolo ronconi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Catholic University of the Sacred Heart</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ronconi</last_name>
      <phone>3477123940</phone>
      <email>gianpaolo.ronconi@unicatt.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>gianpaolo ronconi</last_name>
      <phone>3477123940</phone>
      <email>gianpaolo.ronconi@unicatt.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Gianpaolo Ronconi</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>gianpaolo ronconi</last_name>
        <phone>3477123940</phone>
        <email>gianpaolo.ronconi@unicatt.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.</citation>
      <PMID>3944402</PMID>
    </reference>
    <reference>
      <citation>Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.</citation>
      <PMID>1468055</PMID>
    </reference>
    <reference>
      <citation>EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.</citation>
      <PMID>10109801</PMID>
    </reference>
    <reference>
      <citation>Cohen L, Kobayashi S, Simic M, Dennis S, Refshauge K, Pappas E. Non-radiographic methods of measuring global sagittal balance: a systematic review. Scoliosis Spinal Disord. 2017 Oct 3;12:30. doi: 10.1186/s13013-017-0135-x. eCollection 2017.</citation>
      <PMID>29026895</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
      <mesh_term>Scoliosis</mesh_term>
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012032
  org study id: 4381
  nct id: NCT06012032
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The postural observation of the patient has an important role for the evaluation and
        monitoring of orthopedic and neurological degenerative pathologies. The study of the effects
        of rehabilitation in the treatment of postural alterations depends on the validity,
        sensitivity and specificity of the tool used.
  
        The radiographic evaluation of the spine in the standard anteroposterior and lateral
        projections is the gold standard and provides a standardized and objective measure of the
        dysmorphisms and paramorphisms of the spine, although it requires exposure to X-rays and with
        costs of the method especially in the need to repeat the radiological examination in time.
  
        Non-radiological tools for postural assessment have been proposed in the literature, with
        uncertain judgments by the various authors regarding their validity and reliability, due to
        the heterogeneity and poor quality of the studies in this regard.
  
        The aim of this study is to evaluate the effectiveness of a new posture analysis methodology
        (BHOHB SPINAL-METER ® and CervicalMeter®) in measuring spine dysmorphisms and paramorphisms
        in adult patients affected by orthopedic and neurological degenerative pathologies, who carry
        out rehabilitation at the Policlinico Gemelli Foundation (FPG) Hospitalization and
        Rehabilitation Services clinic. In particular, the correspondence of radiological and
        clinical data with the reports obtained from the "BHOHB SPINAL-METER ® and CervicalMeter®"
        will be considered and the relationship between the data obtained with the two methods and
        the characteristics of pain, disability, balance and quality of life will be observed of
        patients suffering from orthopedic and neurological disease with dysmorphisms and
        paramorphisms of the spine, belonging to the rehabilitation clinic who agree to participate
        in the study.
  Setting: outpatients ward, UOSA( "Unità operativa semplice ambulatoriale" simple outpatient
        operating unit) Rehabilitation Service Hospitalization and FPG Rehabilitation Services.
  
        Duration of the study: 1 year
  
        Goals:
  
        Primary endpoint: evaluation of the correlation of radiological and clinical reports with
        those obtained from the device under study; in particular, the measurement of the
        radiological Cobb angle (from standard X-ray in orthostatism, on a single plate in the
        anteroposterior projection) of the patient will be correlated with that evaluated with the
        BHOHB SPINAL-METER® and CervicalMeter® Secondary end point: evaluation of the effects of
        postural alteration measured radiologically and with the "BHOHB SPINAL-METER ® and
        CervicalMeter®" on static and dynamic balance, on spine pain and on the quality of life of
        patients, evaluated respectively with the measures Berg Balance scale, Tinetti Gait
        Evaluation, NRS (Numeric rating Scale) and with stabilometric examination, which are
        performed routinely in outpatient visits.
  
        Calculation of the sample size: Based on the current literature on the results obtained via
        RX and on the data of the new instrument held by the investigators, in order to estimate a
        Pearson correlation coefficient equal to 0.90, with a width of the interval of 0.10 and a
        bilateral confidence interval of 95%, it is considered necessary to enroll a minimum number
        of patients equal to 62.
  
        Statistical analysis: Qualitative variables will be described through absolute frequencies
        and percentages, while quantitative variables as mean and standard deviation or median and
        interquartile range according to their distribution, which will be tested through the
        Shapiro-Wilk test.
  
        The evaluation of the degree of correlation between the measurement of the radiological Cobb
        angle of the patient with that evaluated with the BHOHB SPINAL-METER ® and CervicalMeter®
        will be performed by calculating the Pearson correlation coefficient, and further exemplified
        by suitable scatter plots.
  
        The effects of postural alteration measured radiologically and with the BHOHB SPINAL-METER ®
        and CervicalMeter®, on static and dynamic balance, spine pain and patients' quality of life
        will be analyzed through univariate and multivariate linear regression models.
  
        A p-value <0.05 will be considered statistically significant. The statistical analyzes will
        be performed using the STATA 16 software.
  observational model: Cohort
  time perspective: Other
  measure: Cobb angle
  time frame: This is a baseline evaluation. The study does not include further evaluations. We aimed to perform a one-time comparison of the Cobb's angle measured through BHOHB SPINAL-METER versus standard spinal radiography
  description: radiographic angle measuring the degree of scoliosis in the frontal plane
  measure: Berg Balance scale
  time frame: This is a baseline evaluation. The study does not include further evaluations. The Berg balance scale score goes from 0 to 56 points. Higher scores indicate low/no balance deficit and low/no risk of falling.
  description: balance scale
  measure: Tinetti scale
  time frame: This is a baseline evaluation. The study does not include further evaluations. The Tinetti scale score goes from 0 to 26. The higher scores indicate a lower risk of falls
  description: balance and deambulation scale
  measure: NRS numeric rating scale for pain
  time frame: This is a baseline evaluation. The study does not include further evaluations. NRS score goes from 0 to 10. Higher scores correspond to worse pain perception.
  description: visual analogical scale for pain assessment
  measure: stabilometric test
  time frame: This is a baseline evaluation. The study does not include further evaluations.
  description: assessment of static balance
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: gianpaolo ronconi
  role: Principal Investigator
  affiliation: Catholic University of the Sacred Heart
  last name: Ronconi
  phone: 3477123940
  email: gianpaolo.ronconi@unicatt.it
  last name: gianpaolo ronconi
  phone: 3477123940
  email: gianpaolo.ronconi@unicatt.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  citation: Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
  PMID: 3944402
  citation: Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
  PMID: 1468055
  citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
  PMID: 10109801
  citation: Cohen L, Kobayashi S, Simic M, Dennis S, Refshauge K, Pappas E. Non-radiographic methods of measuring global sagittal balance: a systematic review. Scoliosis Spinal Disord. 2017 Oct 3;12:30. doi: 10.1186/s13013-017-0135-x. eCollection 2017.
  PMID: 29026895
  responsible party type: Sponsor
  mesh term: Osteoporosis
  mesh term: Scoliosis
  mesh term: Parkinson Disease