<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/NCT03008902</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000394</org_study_id>
    <nct_id>NCT03008902</nct_id>
  </id_info>
  <brief_title>A Study of Effects of Age and Hyperkyphosis on Spine Motion and Loading</brief_title>
  <official_title>A Cross-sectional Study Using Motion Analysis to Determine Whether Age and Hyperkyphosis Are Associated With Thoracic Spine Motion and Loading</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</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>
      We are studying how spine movement changes with age, and when people have vertebral fractures&#xD;
      (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to obtain unique measures of thoracic spinal motion in young,&#xD;
      older, and hyperkyphotic older adults. We will then develop unique subject-specific&#xD;
      musculoskeletal models of these individuals to estimate loads applied to the vertebrae in&#xD;
      vivo, and examine how spinal motion and loading vary with age and increased kyphosis.&#xD;
&#xD;
      Vertebral fractures (VFs) are the most common type of fracture in older adults, occurring in&#xD;
      20-35% of women and 15-25% of men over the age of 50, and are associated with significant&#xD;
      morbidity, increased mortality, and annual costs exceeding $1 billion in the United States.&#xD;
      However, limited understanding of the mechanisms (beyond low vertebral bone mineral density&#xD;
      and strength) that lead to VFs hinders our ability to predict and prevent these injuries.&#xD;
&#xD;
      Similarly, hyperkyphosis, defined as excess forward curvature of the thoracic spine, is&#xD;
      suffered by 20-40% of older adults, but its causes are poorly understood and it has no&#xD;
      standard clinical treatment. Hyperkyphosis and VFs are inter-related, as individuals with VFs&#xD;
      often have worse kyphosis, while hyperkyphosis is an independent risk factor for future VFs.&#xD;
      Hyperkyphosis may increase VF risk through increased vertebral loading, but better&#xD;
      understanding is needed of the biomechanics of this common spine condition.&#xD;
&#xD;
      VFs occur more often at mid-thoracic (T7-T8) and thoraco-lumbar (T12-L1) vertebrae than&#xD;
      elsewhere in the spine, and it has been suggested that biomechanical factors predispose these&#xD;
      areas to fracture by increasing vertebral loading. In the first phase of this project, a&#xD;
      novel musculoskeletal model was developed that uniquely predicts peaks in vertebral loading&#xD;
      around the T12-L1 region of the spine, but this was not observed in the mid-thoracic region.&#xD;
      Our preliminary data suggested that increased thoracic stiffness causes greater vertebral&#xD;
      loading at mid-thoracic levels (T7-T9), while increased thoracic kyphosis increases vertebral&#xD;
      loading, particularly in the thoraco-lumbar (T12-L1) region.&#xD;
&#xD;
      Further advances in musculoskeletal modeling will are needed to fully evaluate these&#xD;
      possibilities, but a particular knowledge gap remains regarding the in vivo kinematics of the&#xD;
      thoracic spine and ribcage in both healthy and hyperkyphotic individuals. This project aims&#xD;
      to fill that gap by producing novel in vivo measurements of thoracic spine motion in young,&#xD;
      older, and hyperkyphotic older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 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>Thoracic spine range of motion, in degrees.</measure>
    <time_frame>Day 1</time_frame>
    <description>Full body movement will be recorded during subject movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Passive reflective marker clusters will be attached to subjects along the spine at T1, T4, T5, T8, T9, T12, L1, and additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Marker positions during subject movements will be recorded with sub-millimeter accuracy using an eight-camera system from Vicon Motion Systems (Centennial, CO). Recorded marker positions will be applied to a musculoskeletal model of the subject through an inverse kinematics algorithm in order to provide estimates of thoracic spine angular range of motion in flexion-extension, lateral bending, and axial rotation during each subject movement.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Kyphosis</condition>
  <condition>Vertebral Fracture</condition>
  <arm_group>
    <arm_group_label>Non-patients</arm_group_label>
    <description>Non-patients, who have not had vertebral fractures or hyperkyphosis, and have not been seen at BIDMC, will be recruited from the community as described in section B3C and B6 below. The non-patient group will consist of 16 healthy adults ages 18-40.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records as described in B3C and B6 below. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Near-infrared passive motion capture recording</intervention_name>
    <description>Full body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions.</description>
    <arm_group_label>Non-patients</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Non-patients&#xD;
&#xD;
        Non-patients, who have not have not been seen at BIDMC for vertebral fractures or&#xD;
        hyperkyphosis, will be recruited from the local community. The non-patient group will&#xD;
        consist of 16 healthy adults ages 18-40.&#xD;
&#xD;
        Patients&#xD;
&#xD;
        Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be&#xD;
        identified by review of medical records. The patient group will consist of 32 adults ages&#xD;
        75 and older who have previously been diagnosed with a thoracic vertebral fracture at&#xD;
        BIDMC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        No exclusion criteria shall be based on race, ethnicity, or sex.&#xD;
&#xD;
        Inclusion Criteria (Non-patient group):&#xD;
&#xD;
          -  Males and females, ages 18 - 40 years&#xD;
&#xD;
          -  Able to perform activities such as walking, standing, sitting, bending or lifting&#xD;
             without assistance&#xD;
&#xD;
          -  Willing to sign informed consent form&#xD;
&#xD;
        Exclusion Criteria (Non-patient group):&#xD;
&#xD;
        • Conditions that might alter thoracic biomechanics: Examples of these include scoliosis, a&#xD;
        history of traumatic thoracic injury or spinal surgery, neuromuscular conditions such as&#xD;
        Parkinson's disease or muscular dystrophy.&#xD;
&#xD;
          -  Body mass index &gt; 30 kg/m2&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Latex allergies&#xD;
&#xD;
          -  Currently taking muscle relaxers, steroids, or narcotics&#xD;
&#xD;
          -  Participation in another research study with radiation exposure&#xD;
&#xD;
          -  Previous exposure to radiation as part of a medical procedure in the past six months&#xD;
&#xD;
          -  Musculoskeletal injury or condition that is currently affecting normal activity or&#xD;
             movement. Examples of this could include sprains, strains, dislocations or fractures&#xD;
             that prevent one from walking, standing, sitting, bending or lifting in a normal&#xD;
             manner.&#xD;
&#xD;
        Inclusion Criteria (Patient group):&#xD;
&#xD;
          -  Males and females, ages 75 years and older.&#xD;
&#xD;
          -  Patients who received a lateral thoracic spine x-ray and had a diagnosis of a&#xD;
             vertebral fracture (ICD9 - 805.2) in the year 2011 or later.&#xD;
&#xD;
          -  At least 6 months since diagnosis of vertebral fracture.&#xD;
&#xD;
          -  Measurable T4-T12 Cobb angle in lateral thoracic spine x-ray.&#xD;
&#xD;
          -  Currently living in the Boston area.&#xD;
&#xD;
          -  Able to perform activities such as walking, standing, sitting, bending or lifting&#xD;
             without assistance&#xD;
&#xD;
          -  Willing to sign informed consent form&#xD;
&#xD;
        Exclusion Criteria (Patient group):&#xD;
&#xD;
        • Conditions (unrelated to vertebral fracture and hyperkyphosis) that might alter thoracic&#xD;
        biomechanics: Examples of these include scoliosis, a history of traumatic thoracic injury&#xD;
        or spinal surgery, neuromuscular conditions such as Parkinson's disease or muscular&#xD;
        dystrophy.&#xD;
&#xD;
          -  Body mass index &gt; 30 kg/m2&#xD;
&#xD;
          -  Latex allergies&#xD;
&#xD;
          -  Currently taking muscle relaxers, steroids, or narcotics&#xD;
&#xD;
          -  Musculoskeletal injury or condition that is currently affecting normal activity or&#xD;
             movement. Examples of this could include sprains, strains, dislocations or fractures&#xD;
             that prevent one from walking, standing, sitting, bending or lifting in a normal&#xD;
             manner.&#xD;
&#xD;
          -  A score ≥10 on the Short Blessed Test, suggesting possible impaired cognitive function&#xD;
             or dementia.&#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>Dennis Anderson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 2, 2018</last_update_submitted>
  <last_update_submitted_qc>October 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Dennis Anderson</investigator_full_name>
    <investigator_title>Staff Scientist II</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kyphosis</mesh_term>
    <mesh_term>Spinal Fractures</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/NCT03008902
org study id: 2015P000394
nct id: NCT03008902
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We are studying how spine movement changes with age, and when people have vertebral fractures
      (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).
The purpose of this study is to obtain unique measures of thoracic spinal motion in young,
      older, and hyperkyphotic older adults. We will then develop unique subject-specific
      musculoskeletal models of these individuals to estimate loads applied to the vertebrae in
      vivo, and examine how spinal motion and loading vary with age and increased kyphosis.

      Vertebral fractures (VFs) are the most common type of fracture in older adults, occurring in
      20-35% of women and 15-25% of men over the age of 50, and are associated with significant
      morbidity, increased mortality, and annual costs exceeding $1 billion in the United States.
      However, limited understanding of the mechanisms (beyond low vertebral bone mineral density
      and strength) that lead to VFs hinders our ability to predict and prevent these injuries.

      Similarly, hyperkyphosis, defined as excess forward curvature of the thoracic spine, is
      suffered by 20-40% of older adults, but its causes are poorly understood and it has no
      standard clinical treatment. Hyperkyphosis and VFs are inter-related, as individuals with VFs
      often have worse kyphosis, while hyperkyphosis is an independent risk factor for future VFs.
      Hyperkyphosis may increase VF risk through increased vertebral loading, but better
      understanding is needed of the biomechanics of this common spine condition.

      VFs occur more often at mid-thoracic (T7-T8) and thoraco-lumbar (T12-L1) vertebrae than
      elsewhere in the spine, and it has been suggested that biomechanical factors predispose these
      areas to fracture by increasing vertebral loading. In the first phase of this project, a
      novel musculoskeletal model was developed that uniquely predicts peaks in vertebral loading
      around the T12-L1 region of the spine, but this was not observed in the mid-thoracic region.
      Our preliminary data suggested that increased thoracic stiffness causes greater vertebral
      loading at mid-thoracic levels (T7-T9), while increased thoracic kyphosis increases vertebral
      loading, particularly in the thoraco-lumbar (T12-L1) region.

      Further advances in musculoskeletal modeling will are needed to fully evaluate these
      possibilities, but a particular knowledge gap remains regarding the in vivo kinematics of the
      thoracic spine and ribcage in both healthy and hyperkyphotic individuals. This project aims
      to fill that gap by producing novel in vivo measurements of thoracic spine motion in young,
      older, and hyperkyphotic older adults.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Thoracic spine range of motion, in degrees.
time frame: Day 1
description: Full body movement will be recorded during subject movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Passive reflective marker clusters will be attached to subjects along the spine at T1, T4, T5, T8, T9, T12, L1, and additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Marker positions during subject movements will be recorded with sub-millimeter accuracy using an eight-camera system from Vicon Motion Systems (Centennial, CO). Recorded marker positions will be applied to a musculoskeletal model of the subject through an inverse kinematics algorithm in order to provide estimates of thoracic spine angular range of motion in flexion-extension, lateral bending, and axial rotation during each subject movement.
arm group label: Non-patients
description: Non-patients, who have not had vertebral fractures or hyperkyphosis, and have not been seen at BIDMC, will be recruited from the community as described in section B3C and B6 below. The non-patient group will consist of 16 healthy adults ages 18-40.
arm group label: Patients
description: Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records as described in B3C and B6 below. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.
intervention type: Procedure
intervention name: Near-infrared passive motion capture recording
description: Full body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions.
arm group label: Non-patients
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis Anderson, Ph.D.
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Dennis Anderson
investigator title: Staff Scientist II
mesh term: Kyphosis
mesh term: Spinal Fractures
sharing ipd: No