<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/NCT03810781</url>
  </required_header>
  <id_info>
    <org_study_id>F2882-P</org_study_id>
    <secondary_id>RX002882-01A1</secondary_id>
    <nct_id>NCT03810781</nct_id>
  </id_info>
  <brief_title>Postural Stability in Cervical Spinal Myelopathy</brief_title>
  <official_title>Study of Postural Stability in Subjects With Myelopathy Using a Portable Virtual Reality Balance Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from&#xD;
      rigors of military service. Balance and posturography are negatively affected in CSM, but&#xD;
      require expensive equipment, and extensive training of personnel for data acquisition and&#xD;
      interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive&#xD;
      construct that could be implemented as an aid in diagnosis and as an objective means to&#xD;
      compare treatment modalities and track recovery. The goal for the SPiRE is to generate the&#xD;
      critical data to support rigorous Merit studies of posturography for assessments of clinical&#xD;
      course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the&#xD;
      SPiRE is successful, is to phase in objective posturography assessments as VA standard of&#xD;
      care in CSM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 administrative hold&#xD;
&#xD;
      Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from&#xD;
      rigors of military service. Diagnosis of CSM involves a set of clinical findings and is&#xD;
      confirmed by imaging the spine.&#xD;
&#xD;
      Gait impairment and disturbances of stance control are hallmarks of CSM and are a consequence&#xD;
      of abnormalities in proprioception due to dorsal column tract damage of the spine. Currently,&#xD;
      gait and balance deficits rely on clinical level assessments and judgement for detection. An&#xD;
      objective measure of posturography has the benefit of: a) quantifying balance-related&#xD;
      disability in CSM, b) facilitating structure-functional assessments in CSM, and c)&#xD;
      quantifying the degree surgical interventions affect posturography and recovery of function&#xD;
      in CSM.&#xD;
&#xD;
      Objective and sensitive means for assessing balance and posturography exist, but are not&#xD;
      routinely incorporated in diagnosis or functional tracking of progress after interventions&#xD;
      such as surgery. A barrier may be accessibility of posturography and ease of assessments. The&#xD;
      Virtual Environment TBI Screen (VETS) was devised using Army Rapid Innovation Development&#xD;
      funding to objectively assess balance and posturography in a cost effective, but sensitive&#xD;
      manner. VETS involves virtual environments and computerized posturography and is proving to&#xD;
      be a sensitive system facilitating diagnosis, treatment, and mitigation of balance&#xD;
      dysfunction associated with mTBI.&#xD;
&#xD;
      The working hypothesis is VETS testing will enhance clinical judgements regarding CSM. The&#xD;
      SPiRE is designed to provide data critical to a more extensive program of research&#xD;
      incorporating posturography into treatment and rehabilitation of CSM.&#xD;
&#xD;
      First, a limited comparative study of standing balance will be conducted of 20 Veterans being&#xD;
      evaluated for cervical spine surgery to treat CSM and 20 otherwise healthy Veterans. Second,&#xD;
      posturography of the Veterans undergoing surgery to treat CSM will be tracked during their&#xD;
      scheduled follow up visits to determine the degree VETS scores are affected by surgery and to&#xD;
      track recovery from CSM.&#xD;
&#xD;
      Patients in the CSM group will be selected based on clinical criteria. Veterans in the&#xD;
      control group will be recruited from the Syracuse Veterans Affairs Medical Center (SVAMC) and&#xD;
      surrounding community.&#xD;
&#xD;
      For VETS testing, the Veteran will stand directly on a firm surface or foam pad placed on top&#xD;
      of a Wii Balance Board (WBB). There are six conditions manipulating surface (firm or foam&#xD;
      surface) and visual input (eyes open viewing a static scene, eyes closed, and eyes open&#xD;
      viewing a dynamic visual scene). The primary measure is the center of pressure (COP) sway&#xD;
      area. These 6 conditions allow for an assessment of generalized vs specific deficits in COP&#xD;
      sway area considering proprioception, dependence of visual input and visuo-proprioceptive&#xD;
      integration.&#xD;
&#xD;
      AIM 1A: Determine whether and to what degree balance is altered in CSM. The degree of COP&#xD;
      sway will be compared between CSM and controls in the six conditions comprising VETS testing.&#xD;
&#xD;
      AIM 1B: Determine whether VETS enhances sensitivity and selectivity in the diagnosis of CSM.&#xD;
      Composite measures of balance will be related to clinical assessment tools and their&#xD;
      relationship with MRI.&#xD;
&#xD;
      AIM 2: Evaluate the VETS scores after surgery to treat CSM. The degree of COP sway area under&#xD;
      the 6 conditions will be compared before surgery, 2 weeks, 6 weeks and 6 months after surgery&#xD;
      (corresponding with post-operative clinical assessments).&#xD;
&#xD;
      The ultimate goal is to validate and incorporate objective balance testing into routine&#xD;
      assessment for CSM to aid in disambiguating CSM, to improve functional assessments of&#xD;
      recovery, and to aid in evaluations of different treatment and rehabilitation strategies in&#xD;
      CSM for the Veteran population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">September 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virtual Environment TBI System (VETS) assessment of Static Posturography</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>The postural stability task involves six conditions during which veterans are instructed to look straight ahead and maintain an upright stance as stably as possible. Veterans are barefooted with feet comfortably placed ~25 cm apart. The six conditions are (1) Eyes Open (EO) Firm (2) Eyes Closed (EC) Firm, (3) Dynamic Scene (DYN) Firm, (4) EO Foam, (5) EC Foam, and (6) DYN Foam. Each condition is tested three times with the average center of pressure (COP) sway area used as a index of stability for that condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Posturography</measure>
    <time_frame>Presurgery compared to 2 weeks, 6 weeks, and 6 months post-surgery. The Post-surgery endpoints are normally scheduled clinical follow ups.</time_frame>
    <description>It is expected that posturography, especially that from FOAM and EC conditions will be improved be surgical relief. This is a within comparison of veterans with CSM and receiving surgical relief through widening of the chord.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nurick Scale</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>The Nurick scale is a 6-grade ordinal scale assessing gait impairment, with grades ranging from 0 (signs and symptoms of root involvement but no evidence of spinal cord disease) to 5 (chair bound or bedridden). The aggregate value of the Nurick scale will be related to posturography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>The NDI is a 10-item questionnaire addressing function activities (personal care, lifting, reading, work, driving, sleeping, and recreation), pain intensity, concentration, and headache. For each item, patients make their ratings on a 6-point Likert scale with values 0 = no disability and 5 = complete disability. Summed scores for each category are multiplied by 2 to give a total NDI score ranging from 0-100. NDI will be related to VETS posturography to determine the sensitivity of standing posture to degree of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 version 2 (SF-36v2)</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>The SF-36v2 is a general health survey that includes mental and physical component scores to measure functional status and overall quality of life. The instrument includes 8 scales: physical functioning, role limitations physical pain, bodily pain, general health perceptions, vitality, social functioning, role limitations, emotional health, and mental health. The higher the score the more limitations. The total scale will be used to determine the sensitivity of VETS posturography to quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EC FIRM/EO FIRM ratio</measure>
    <time_frame>PreSurgery</time_frame>
    <description>From the VETS, a ratio corresponding to the Rhomberg ratio of COP sway will be used to determine the degree static posture depends on visual input.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EO FOAM/EO FIRM</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>From the VETS, a ratio of COP sway will be used to determine the degree static posture is affected by reduced proprioception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EC FOAM/EO FOAM ratio</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>From the VETS, a ratio of COP sway will be used to determine the degree loss of visual information compounds reduced proprioception in static balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DYN FOAM/DYN FIRM ratio</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>From the VETS, a ratio of COP sway to determine the roll vection is induced by loss of proprioception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DYN FIRM/ EO FIRM ratio</measure>
    <time_frame>PreSurgery compared to otherwise healthy veterans</time_frame>
    <description>From the VETS, a ration of COP sway to determine the degree roll vection is induced.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Cervical Spondylotic Myelopathy</condition>
  <arm_group>
    <arm_group_label>Cervical Spondylotic Myelopathy (CSM)</arm_group_label>
    <description>Degenerative cervical myelopathy, encapsulates a cascade of events leading to significant degenerative changes in discs, formation of osteophytes, facet hypertrophy, calcification of the posterior longitudinal ligament and ligamentous flavum with resultant canal stenosis and segmental instability.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        US Veterans.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients in the CSM group will be selected based on clinical criteria. Inclusion criteria&#xD;
        for the CSM group are:&#xD;
&#xD;
          -  symptoms of myelopathy in upper and lower extremities and stenosis of the cervical&#xD;
             spine demonstrated by MRI or myelography&#xD;
&#xD;
          -  lower extremity muscle strength of 4 as quantified by manual muscle test (MMT) 36 or&#xD;
             above&#xD;
&#xD;
          -  ability to stand without support with eyes closed for 30 s or more&#xD;
&#xD;
          -  Veterans in the control group will be recruited from the SVAMC and surrounding&#xD;
             community using printed advertisements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria for all study participants are:&#xD;
&#xD;
          -  presence of lower extremity or lumbar spine disease&#xD;
&#xD;
          -  peripheral neuropathy&#xD;
&#xD;
          -  history of other neurological disorder&#xD;
&#xD;
          -  inability to stand in an upright position with both feet together and eyes closed&#xD;
&#xD;
          -  Although the SVAMC population is predominately Caucasian and male, every effort will&#xD;
             be made to recruit minorities and women&#xD;
&#xD;
          -  The proposed study will neither target for recruitment nor will the investigators&#xD;
             exclude pregnant women&#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>Richard J. Servatius, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse VA Medical Center, Syracuse, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syracuse VA Medical Center, Syracuse, NY</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Posturography</keyword>
  <keyword>Spinal Cord Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Bone Marrow Diseases</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/NCT03810781
org study id: F2882-P
secondary id: RX002882-01A1
nct id: NCT03810781
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from
      rigors of military service. Balance and posturography are negatively affected in CSM, but
      require expensive equipment, and extensive training of personnel for data acquisition and
      interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive
      construct that could be implemented as an aid in diagnosis and as an objective means to
      compare treatment modalities and track recovery. The goal for the SPiRE is to generate the
      critical data to support rigorous Merit studies of posturography for assessments of clinical
      course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the
      SPiRE is successful, is to phase in objective posturography assessments as VA standard of
      care in CSM.
COVID-19 administrative hold

      Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from
      rigors of military service. Diagnosis of CSM involves a set of clinical findings and is
      confirmed by imaging the spine.

      Gait impairment and disturbances of stance control are hallmarks of CSM and are a consequence
      of abnormalities in proprioception due to dorsal column tract damage of the spine. Currently,
      gait and balance deficits rely on clinical level assessments and judgement for detection. An
      objective measure of posturography has the benefit of: a) quantifying balance-related
      disability in CSM, b) facilitating structure-functional assessments in CSM, and c)
      quantifying the degree surgical interventions affect posturography and recovery of function
      in CSM.

      Objective and sensitive means for assessing balance and posturography exist, but are not
      routinely incorporated in diagnosis or functional tracking of progress after interventions
      such as surgery. A barrier may be accessibility of posturography and ease of assessments. The
      Virtual Environment TBI Screen (VETS) was devised using Army Rapid Innovation Development
      funding to objectively assess balance and posturography in a cost effective, but sensitive
      manner. VETS involves virtual environments and computerized posturography and is proving to
      be a sensitive system facilitating diagnosis, treatment, and mitigation of balance
      dysfunction associated with mTBI.

      The working hypothesis is VETS testing will enhance clinical judgements regarding CSM. The
      SPiRE is designed to provide data critical to a more extensive program of research
      incorporating posturography into treatment and rehabilitation of CSM.

      First, a limited comparative study of standing balance will be conducted of 20 Veterans being
      evaluated for cervical spine surgery to treat CSM and 20 otherwise healthy Veterans. Second,
      posturography of the Veterans undergoing surgery to treat CSM will be tracked during their
      scheduled follow up visits to determine the degree VETS scores are affected by surgery and to
      track recovery from CSM.

      Patients in the CSM group will be selected based on clinical criteria. Veterans in the
      control group will be recruited from the Syracuse Veterans Affairs Medical Center (SVAMC) and
      surrounding community.

      For VETS testing, the Veteran will stand directly on a firm surface or foam pad placed on top
      of a Wii Balance Board (WBB). There are six conditions manipulating surface (firm or foam
      surface) and visual input (eyes open viewing a static scene, eyes closed, and eyes open
      viewing a dynamic visual scene). The primary measure is the center of pressure (COP) sway
      area. These 6 conditions allow for an assessment of generalized vs specific deficits in COP
      sway area considering proprioception, dependence of visual input and visuo-proprioceptive
      integration.

      AIM 1A: Determine whether and to what degree balance is altered in CSM. The degree of COP
      sway will be compared between CSM and controls in the six conditions comprising VETS testing.

      AIM 1B: Determine whether VETS enhances sensitivity and selectivity in the diagnosis of CSM.
      Composite measures of balance will be related to clinical assessment tools and their
      relationship with MRI.

      AIM 2: Evaluate the VETS scores after surgery to treat CSM. The degree of COP sway area under
      the 6 conditions will be compared before surgery, 2 weeks, 6 weeks and 6 months after surgery
      (corresponding with post-operative clinical assessments).

      The ultimate goal is to validate and incorporate objective balance testing into routine
      assessment for CSM to aid in disambiguating CSM, to improve functional assessments of
      recovery, and to aid in evaluations of different treatment and rehabilitation strategies in
      CSM for the Veteran population.
observational model: Case-Control
time perspective: Prospective
measure: Virtual Environment TBI System (VETS) assessment of Static Posturography
time frame: PreSurgery compared to otherwise healthy veterans
description: The postural stability task involves six conditions during which veterans are instructed to look straight ahead and maintain an upright stance as stably as possible. Veterans are barefooted with feet comfortably placed ~25 cm apart. The six conditions are (1) Eyes Open (EO) Firm (2) Eyes Closed (EC) Firm, (3) Dynamic Scene (DYN) Firm, (4) EO Foam, (5) EC Foam, and (6) DYN Foam. Each condition is tested three times with the average center of pressure (COP) sway area used as a index of stability for that condition.
measure: Change in Posturography
time frame: Presurgery compared to 2 weeks, 6 weeks, and 6 months post-surgery. The Post-surgery endpoints are normally scheduled clinical follow ups.
description: It is expected that posturography, especially that from FOAM and EC conditions will be improved be surgical relief. This is a within comparison of veterans with CSM and receiving surgical relief through widening of the chord.
measure: Nurick Scale
time frame: PreSurgery compared to otherwise healthy veterans
description: The Nurick scale is a 6-grade ordinal scale assessing gait impairment, with grades ranging from 0 (signs and symptoms of root involvement but no evidence of spinal cord disease) to 5 (chair bound or bedridden). The aggregate value of the Nurick scale will be related to posturography.
measure: Neck Disability Index (NDI)
time frame: PreSurgery compared to otherwise healthy veterans
description: The NDI is a 10-item questionnaire addressing function activities (personal care, lifting, reading, work, driving, sleeping, and recreation), pain intensity, concentration, and headache. For each item, patients make their ratings on a 6-point Likert scale with values 0 = no disability and 5 = complete disability. Summed scores for each category are multiplied by 2 to give a total NDI score ranging from 0-100. NDI will be related to VETS posturography to determine the sensitivity of standing posture to degree of disability.
measure: Short Form-36 version 2 (SF-36v2)
time frame: PreSurgery compared to otherwise healthy veterans
description: The SF-36v2 is a general health survey that includes mental and physical component scores to measure functional status and overall quality of life. The instrument includes 8 scales: physical functioning, role limitations physical pain, bodily pain, general health perceptions, vitality, social functioning, role limitations, emotional health, and mental health. The higher the score the more limitations. The total scale will be used to determine the sensitivity of VETS posturography to quality of life.
measure: EC FIRM/EO FIRM ratio
time frame: PreSurgery
description: From the VETS, a ratio corresponding to the Rhomberg ratio of COP sway will be used to determine the degree static posture depends on visual input.
measure: EO FOAM/EO FIRM
time frame: PreSurgery compared to otherwise healthy veterans
description: From the VETS, a ratio of COP sway will be used to determine the degree static posture is affected by reduced proprioception.
measure: EC FOAM/EO FOAM ratio
time frame: PreSurgery compared to otherwise healthy veterans
description: From the VETS, a ratio of COP sway will be used to determine the degree loss of visual information compounds reduced proprioception in static balance.
measure: DYN FOAM/DYN FIRM ratio
time frame: PreSurgery compared to otherwise healthy veterans
description: From the VETS, a ratio of COP sway to determine the roll vection is induced by loss of proprioception.
measure: DYN FIRM/ EO FIRM ratio
time frame: PreSurgery compared to otherwise healthy veterans
description: From the VETS, a ration of COP sway to determine the degree roll vection is induced.
arm group label: Cervical Spondylotic Myelopathy (CSM)
description: Degenerative cervical myelopathy, encapsulates a cascade of events leading to significant degenerative changes in discs, formation of osteophytes, facet hypertrophy, calcification of the posterior longitudinal ligament and ligamentous flavum with resultant canal stenosis and segmental instability.
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: Richard J. Servatius, PhD
role: Principal Investigator
affiliation: Syracuse VA Medical Center, Syracuse, NY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Cord Diseases
mesh term: Bone Marrow Diseases
sharing ipd: No