<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/NCT04498806</url>
  </required_header>
  <id_info>
    <org_study_id>113995</org_study_id>
    <nct_id>NCT04498806</nct_id>
  </id_info>
  <brief_title>Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy</brief_title>
  <official_title>Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy With Surgical Decompression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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 investigators objective of this research is to compare activity monitor results with&#xD;
      standard of care (SOC) question-based outcome measures for degenerative cervical myelopathy&#xD;
      patients before and after treatment with decompression.&#xD;
&#xD;
      Understanding of the relationship between activity monitor data and question-based outcome&#xD;
      measures in the context of degenerative cervical myelopathy will improve our understanding of&#xD;
      the disease and limit the effort to diagnose and monitor it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Degenerative cervical myelopathy (DCM) is the most common cause of spinal dysfunction across&#xD;
      the world and a major cause of disability. DCM describes a group of conditions that&#xD;
      progressively impinge on the spinal cord resulting in functional impairment and a reduced&#xD;
      quality of life. Degenerative diseases of the spine increase in prevalence with increases in&#xD;
      age. A cadaver study of 469 adults found cervical stenosis of at least one level in 19.2% of&#xD;
      adults, 24.5% in those older than 50 and 27% of those older than 70 years. By 2050 the global&#xD;
      population over 60 years of age is expected to approach 2 billion. DCM is certainly a&#xD;
      prevalent disease in the elderly and will only become more common. For these reasons DCM must&#xD;
      be addressed thoroughly in research to improve outcomes.&#xD;
&#xD;
      Symptoms of afflicted patients often include neck pain, numbness/clumsiness in the hands,&#xD;
      weakness, upper and lower extremity motor deficits, balance and gait impairment, among&#xD;
      others. Non-surgical treatment has limited efficacy, while early surgical treatment is&#xD;
      recommended to halt progression, initiate recovery and improve symptoms. Surgical treatment&#xD;
      is widely agreed upon, yet measurement of surgical outcomes can be challenging.&#xD;
&#xD;
      Traditionally, assessment of outcomes has been performed subjectively using&#xD;
      questionnaires/functional assessments. These question-based outcome measures are popular due&#xD;
      to practicality and ease of administration. Examples that have been used in Degenerative&#xD;
      Cervical Myelopathy (DCM) include Neck Disability Index (NDI), Myelopathy Disability Index&#xD;
      (MDI), Japanese Orthopedic Association (JOA), European Myelopathy Score (EMS), Nurick Score,&#xD;
      Ranawat Score, Odom's criteria and Short Form-36 survey (SF-36). This introduces&#xD;
      incompatibility when comparing studies using different questionnaires. In addition to the&#xD;
      lack of consensus in a standard questionnaire, there are inherent biases in the use of&#xD;
      self-reported measures. Self-reported questionnaires and objective disability measures do not&#xD;
      always agree, particularly when recent setbacks distort a patients' perception of total&#xD;
      improvement. Personal evaluation is subject to inherent bias with a disconnect between&#xD;
      perception of disability and actual objective performance.&#xD;
&#xD;
      Gait disturbance may be the most be the most prominent physical finding in DCM, and walking&#xD;
      tests have been established as effective, objective measures in DCM pre and post-operatively.&#xD;
      A patient's activity level at home provides valuable data on recovery and surgical efficacy,&#xD;
      yet prior to wearable technology required self-reported data. Accelerometers have been used&#xD;
      to remedy this problem by measuring activity trends in a quantifiable manner, without relying&#xD;
      on the subjective response of the patient. They have recently been implemented in orthopedic&#xD;
      research. Investigators have compared self-rated disability with objective accelerometer data&#xD;
      in patients suffering from lumbar spinal stenosis (LSS) and found self-rated disability did&#xD;
      not always reflect objective data. Some investigators used these methods to objectively&#xD;
      measure function after surgical intervention, lumbar spinal stenosis decompression. Results&#xD;
      are promising and require further investigation into the application of this new tool.&#xD;
&#xD;
      In summary accelerometers offer longitudinal objective measurement of walking and the ability&#xD;
      to look at trends in activity levels. Eventually walking measures could be used to monitor&#xD;
      patients with mild myelopathy for progression and possibly even be part of a remote screening&#xD;
      tool (i.e. a phone tracks walking distance, speed, number of falls per month and prompts for&#xD;
      monthly or quarterly handwriting samples). We aim to apply similar concepts of prior&#xD;
      investigations to compare accelerometer and question-based outcome data on DCM patients&#xD;
      before and after undergoing surgical intervention, to determine the most practical and&#xD;
      accurate method for outcome measurement. By incorporating activity monitor data and looking&#xD;
      at relationships between the different measures, we will be able to better understand the&#xD;
      disease and limit the effort required to diagnose and monitor it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level</measure>
    <time_frame>Follow Up Visit at 6-8 weeks</time_frame>
    <description>Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level</measure>
    <time_frame>Follow Up Visit at 3-months</time_frame>
    <description>Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level</measure>
    <time_frame>Follow Up Visit at 6-months</time_frame>
    <description>Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cervical Myelopathy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-op appointment, patient will receive Fitbit device to track physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fitbit</intervention_name>
    <description>The Fitbit device monitors daily activity as a measure of physical function.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 +&#xD;
&#xD;
          -  Without known injuries or compounding disability&#xD;
&#xD;
          -  Without prior-to-injury activity limitations&#xD;
&#xD;
          -  Moderate to severe degenerative cervical pathology&#xD;
&#xD;
          -  Undergoing decompression surgery&#xD;
&#xD;
          -  Has a personal smartphone with the capability to download the Fitbit app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to comply with study protocol&#xD;
&#xD;
          -  Known injuries or compounding disability&#xD;
&#xD;
          -  Prior-to-injury activity limitations&#xD;
&#xD;
          -  Inability to ambulate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Spiker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah Orthopedics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Ryan Spiker</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>cervical myelopathy</keyword>
  <keyword>surgical decompression</keyword>
  <keyword>activity monitors</keyword>
  <keyword>Fitbit</keyword>
  <keyword>physical function</keyword>
  <keyword>steps</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>
  <!-- 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/NCT04498806
org study id: 113995
nct id: NCT04498806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators objective of this research is to compare activity monitor results with
      standard of care (SOC) question-based outcome measures for degenerative cervical myelopathy
      patients before and after treatment with decompression.

      Understanding of the relationship between activity monitor data and question-based outcome
      measures in the context of degenerative cervical myelopathy will improve our understanding of
      the disease and limit the effort to diagnose and monitor it.
Degenerative cervical myelopathy (DCM) is the most common cause of spinal dysfunction across
      the world and a major cause of disability. DCM describes a group of conditions that
      progressively impinge on the spinal cord resulting in functional impairment and a reduced
      quality of life. Degenerative diseases of the spine increase in prevalence with increases in
      age. A cadaver study of 469 adults found cervical stenosis of at least one level in 19.2% of
      adults, 24.5% in those older than 50 and 27% of those older than 70 years. By 2050 the global
      population over 60 years of age is expected to approach 2 billion. DCM is certainly a
      prevalent disease in the elderly and will only become more common. For these reasons DCM must
      be addressed thoroughly in research to improve outcomes.

      Symptoms of afflicted patients often include neck pain, numbness/clumsiness in the hands,
      weakness, upper and lower extremity motor deficits, balance and gait impairment, among
      others. Non-surgical treatment has limited efficacy, while early surgical treatment is
      recommended to halt progression, initiate recovery and improve symptoms. Surgical treatment
      is widely agreed upon, yet measurement of surgical outcomes can be challenging.

      Traditionally, assessment of outcomes has been performed subjectively using
      questionnaires/functional assessments. These question-based outcome measures are popular due
      to practicality and ease of administration. Examples that have been used in Degenerative
      Cervical Myelopathy (DCM) include Neck Disability Index (NDI), Myelopathy Disability Index
      (MDI), Japanese Orthopedic Association (JOA), European Myelopathy Score (EMS), Nurick Score,
      Ranawat Score, Odom's criteria and Short Form-36 survey (SF-36). This introduces
      incompatibility when comparing studies using different questionnaires. In addition to the
      lack of consensus in a standard questionnaire, there are inherent biases in the use of
      self-reported measures. Self-reported questionnaires and objective disability measures do not
      always agree, particularly when recent setbacks distort a patients' perception of total
      improvement. Personal evaluation is subject to inherent bias with a disconnect between
      perception of disability and actual objective performance.

      Gait disturbance may be the most be the most prominent physical finding in DCM, and walking
      tests have been established as effective, objective measures in DCM pre and post-operatively.
      A patient's activity level at home provides valuable data on recovery and surgical efficacy,
      yet prior to wearable technology required self-reported data. Accelerometers have been used
      to remedy this problem by measuring activity trends in a quantifiable manner, without relying
      on the subjective response of the patient. They have recently been implemented in orthopedic
      research. Investigators have compared self-rated disability with objective accelerometer data
      in patients suffering from lumbar spinal stenosis (LSS) and found self-rated disability did
      not always reflect objective data. Some investigators used these methods to objectively
      measure function after surgical intervention, lumbar spinal stenosis decompression. Results
      are promising and require further investigation into the application of this new tool.

      In summary accelerometers offer longitudinal objective measurement of walking and the ability
      to look at trends in activity levels. Eventually walking measures could be used to monitor
      patients with mild myelopathy for progression and possibly even be part of a remote screening
      tool (i.e. a phone tracks walking distance, speed, number of falls per month and prompts for
      monthly or quarterly handwriting samples). We aim to apply similar concepts of prior
      investigations to compare accelerometer and question-based outcome data on DCM patients
      before and after undergoing surgical intervention, to determine the most practical and
      accurate method for outcome measurement. By incorporating activity monitor data and looking
      at relationships between the different measures, we will be able to better understand the
      disease and limit the effort required to diagnose and monitor it.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
time frame: Follow Up Visit at 6-8 weeks
description: Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
measure: Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
time frame: Follow Up Visit at 3-months
description: Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
measure: Number of accrued steps in patients with degenerative cervical myelopathy with surgical decompression assessed by Fitbit activity level
time frame: Follow Up Visit at 6-months
description: Measurement of steps accrued (#) will be collected via the Fitbit software, Fitabase.
arm group label: Intervention
arm group type: Experimental
description: Pre-op appointment, patient will receive Fitbit device to track physical activity.
intervention type: Other
intervention name: Fitbit
description: The Fitbit device monitors daily activity as a measure of physical function.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ryan Spiker, M.D.
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Ryan Spiker
investigator title: Principle Investigator
mesh term: Spinal Cord Diseases
mesh term: Bone Marrow Diseases