<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/NCT04434235</url>
  </required_header>
  <id_info>
    <org_study_id>2019-00830</org_study_id>
    <nct_id>NCT04434235</nct_id>
  </id_info>
  <brief_title>Effects of Additional Axial Load on Cervical Motor Control</brief_title>
  <acronym>Axial</acronym>
  <official_title>Effects of Additional Axial Load on Cervical Motor Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balgrist University Hospital</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>
      he objective of this study is to examine the influence of additional axial load abd body&#xD;
      position on cervical motor control in young healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Motor control of the cervical spine is impotent for responsible for maintaining balance&#xD;
      during daily living activities and to withstand external loads. Stabilization-aspects of the&#xD;
      cervical spine is very complex, passive (ligaments, joint capsule and the skin and active&#xD;
      (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and&#xD;
      exercises like head and neck position sense testing and re-training have been an integral&#xD;
      part of rehabilitation. Another method to evaluate spinal motor control is the assessment of&#xD;
      spinal stiffness. The main objective of this study is to explore the effects of additional&#xD;
      axial loading on motion control in healthy individuals. Does the motor control of the&#xD;
      cervical spine in healthy subjects change with additional axial load or body position? A&#xD;
      better understanding of spinal stiffness and neck position sense leads to novel insights into&#xD;
      spinal cervical stabilization mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of neck joint-position error between differnent weight conditions</measure>
    <time_frame>20 minutes group cervical stiffness</time_frame>
    <description>Joint-position error will be will be assessed with Sensomove. It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with and without additional axial load will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of neck joint-position error between two sitting positions</measure>
    <time_frame>20 minutes group Dynamic cervical stability</time_frame>
    <description>Joint-position error will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with axial load (3kg) between two sitting positions will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of neck range of motion between different weight conditions</measure>
    <time_frame>20 minutes group cervical stiffness</time_frame>
    <description>Range of motion will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Rage of motion with and without additional axial load will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of spinal stiffness between different sitting positions and loading conditions</measure>
    <time_frame>20 minutes group cervical stiffness</time_frame>
    <description>The device measures tissue compliance according to the concept of impulse-response. A force of exact 20 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 20 Newton and 40 Newton. The change of spinal stiffness due sitting position and loading will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during measuring</measure>
    <time_frame>2 minutes</time_frame>
    <description>The visual analogue scale will be used to quantify pain, if any of the measurements is painful. The participant is asked to rate his pain intensity on a straight line (100mm) with two endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-administered neck mobility</measure>
    <time_frame>4 minutes</time_frame>
    <description>Self-administered neck mobility questionnaire is a self-administered questionnaire that uses visual analog scales to measure pain-free active rage of motion for all neck movements. The patient is asked to place a mark on a 100 mm line (0 mm = &quot;no movement possible&quot; and 100 mm = &quot;as far as possible&quot;). The total score is the sum of the individual scores (min. score (600) = no restrictions and max. score (0) = total restriction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>4 minutes</time_frame>
    <description>The Neck Disability Index is a self-report questionnaire with 10-items: pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Dynamic cervical stability</arm_group_label>
    <description>The participant is asked to move the head in 6 directions in a sitting position and 30° leaning backward sitting position; lateral flexion (left / right), flexion, extension, and rotation (left / right). Results are to be taken for each direction and random at each axial load-level (0 kg, 1kg, 2 kg, and 3 kg). In total 24 measurements.&#xD;
The duration of all measurement will be 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical Stiffness</arm_group_label>
    <description>The participant is asked to move the head in 4 directions; flexion, extension, and rotation (left / right). Joint-Position Error measurements will be executed in neutral sitting position. Additionally, stiffness will be measured in neutral sitting position and neutral sitting position with 45° cervical flexion. All measurements will be performed with 0 kg and 3 kg axal loading. In total 18 measurements.The duration of all measurement will be 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>axial load</intervention_name>
    <description>With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine</description>
    <arm_group_label>Cervical Stiffness</arm_group_label>
    <arm_group_label>Dynamic cervical stability</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Young healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy participant's Signed informed consent after being informed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Acute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score &gt; 15&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaap Swanenburg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balgrist University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zürich</city>
        <state>ZH</state>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical spine</keyword>
  <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/NCT04434235
org study id: 2019-00830
nct id: NCT04434235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
he objective of this study is to examine the influence of additional axial load abd body
      position on cervical motor control in young healthy adults.
Motor control of the cervical spine is impotent for responsible for maintaining balance
      during daily living activities and to withstand external loads. Stabilization-aspects of the
      cervical spine is very complex, passive (ligaments, joint capsule and the skin and active
      (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and
      exercises like head and neck position sense testing and re-training have been an integral
      part of rehabilitation. Another method to evaluate spinal motor control is the assessment of
      spinal stiffness. The main objective of this study is to explore the effects of additional
      axial loading on motion control in healthy individuals. Does the motor control of the
      cervical spine in healthy subjects change with additional axial load or body position? A
      better understanding of spinal stiffness and neck position sense leads to novel insights into
      spinal cervical stabilization mechanisms.
observational model: Cohort
time perspective: Cross-Sectional
measure: Change of neck joint-position error between differnent weight conditions
time frame: 20 minutes group cervical stiffness
description: Joint-position error will be will be assessed with Sensomove. It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with and without additional axial load will be assessed.
measure: Change of neck joint-position error between two sitting positions
time frame: 20 minutes group Dynamic cervical stability
description: Joint-position error will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Joint-Position Error with axial load (3kg) between two sitting positions will be assessed.
measure: Change of neck range of motion between different weight conditions
time frame: 20 minutes group cervical stiffness
description: Range of motion will be will be assessed with Sensomove It consists of the 3D senscoordination sensor, an adjustable headband, and basic software for motion feedback of head movements. The change of Rage of motion with and without additional axial load will be assessed.
measure: Change of spinal stiffness between different sitting positions and loading conditions
time frame: 20 minutes group cervical stiffness
description: The device measures tissue compliance according to the concept of impulse-response. A force of exact 20 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 20 Newton and 40 Newton. The change of spinal stiffness due sitting position and loading will be assessed.
measure: Pain during measuring
time frame: 2 minutes
description: The visual analogue scale will be used to quantify pain, if any of the measurements is painful. The participant is asked to rate his pain intensity on a straight line (100mm) with two endpoints.
measure: Self-administered neck mobility
time frame: 4 minutes
description: Self-administered neck mobility questionnaire is a self-administered questionnaire that uses visual analog scales to measure pain-free active rage of motion for all neck movements. The patient is asked to place a mark on a 100 mm line (0 mm = "no movement possible" and 100 mm = "as far as possible"). The total score is the sum of the individual scores (min. score (600) = no restrictions and max. score (0) = total restriction)
measure: Neck Disability Index
time frame: 4 minutes
description: The Neck Disability Index is a self-report questionnaire with 10-items: pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50.
arm group label: Dynamic cervical stability
description: The participant is asked to move the head in 6 directions in a sitting position and 30° leaning backward sitting position; lateral flexion (left / right), flexion, extension, and rotation (left / right). Results are to be taken for each direction and random at each axial load-level (0 kg, 1kg, 2 kg, and 3 kg). In total 24 measurements.
The duration of all measurement will be 60 minutes.
arm group label: Cervical Stiffness
description: The participant is asked to move the head in 4 directions; flexion, extension, and rotation (left / right). Joint-Position Error measurements will be executed in neutral sitting position. Additionally, stiffness will be measured in neutral sitting position and neutral sitting position with 45° cervical flexion. All measurements will be performed with 0 kg and 3 kg axal loading. In total 18 measurements.The duration of all measurement will be 60 minutes.
intervention type: Other
intervention name: axial load
description: With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine
arm group label: Cervical Stiffness
arm group label: Dynamic cervical stability
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jaap Swanenburg, PhD
role: Principal Investigator
affiliation: Balgrist University Hospital
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No