<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/NCT03016286</url>
  </required_header>
  <id_info>
    <org_study_id>BMR20171</org_study_id>
    <nct_id>NCT03016286</nct_id>
  </id_info>
  <brief_title>Bone Myoregulation Reflex &amp; Presynaptic Ia Inhibition</brief_title>
  <official_title>Effects of Cooling of Ankle on Bone Myoregulation Reflex Response and Presynaptic Ia Inhibition Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagcilar Training and Research 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>
      Hypotheses of this study are&#xD;
&#xD;
        1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body&#xD;
           vibration (WBV)&#xD;
&#xD;
        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this&#xD;
           study is to test these hypotheses.&#xD;
&#xD;
      Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at&#xD;
      35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20&#xD;
      minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of&#xD;
      the right ankle, and during WBV respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses of this study are&#xD;
&#xD;
        1. Bone myoregulation reflex (BMR) inhibits presynaptically T-reflex during whole-body&#xD;
           vibration (WBV)&#xD;
&#xD;
        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus T-reflex Aim of this&#xD;
           study is to test these hypotheses.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      Ten young, healthy and right hand dominant male adult volunteers will be included in this&#xD;
      study.&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      Prior to the induction of WBV, control T-reflex recordings will be elicited and then the&#xD;
      participants will complete a 15-s trial WBV protocol to familiarize themselves with the&#xD;
      procedure. Following the control T-reflex recordings, the trial protocol and a 15-s rest, the&#xD;
      participants will receive one session WBV. T-reflex will be recorded during WBV. Then, cold&#xD;
      pack will be applied to the right ankle for 20 minutes. T-reflex will be recorded during the&#xD;
      cooling of the ankle. Then, the participants will receive one session WBV, again. T-reflex&#xD;
      will be recorded during WBV.&#xD;
&#xD;
      A light (2.9 gr.) triaxial (x, y and z-axis) accelerometer (LIS344ALH, ECOPACK®) will be&#xD;
      taped on the right Achilles tendon so that the z-axis will be perpendicular with the&#xD;
      direction of the tendon (Achilles accelerometer). A custom-made reflex hammer will be used to&#xD;
      tap the right Achilles tendon just caudal to the accelerometer. The intensity of tapping will&#xD;
      be about 19.6 N WBV frequencies of 35 Hz will be delivered for 60 s. The vibration plate of&#xD;
      WBV device (Power-Plate®Pro5, PowerPlate® International, Ltd. London, UK) oscillates with a&#xD;
      linear movement upward and downward. The participants will be barefooted and stand directly&#xD;
      on the vibration platform. The surface electromyography (SEMG) data will be obtained while&#xD;
      the participants stand upright on the vibration platform with the knees in extension. The&#xD;
      Ag/AgCl electrodes (KENDALL®Covidien) with a disc radius of 10 mm will be placed 20 mm apart&#xD;
      on the right soleus muscle belly on shaved skin in accordance with the recommendations of the&#xD;
      Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) project .&#xD;
&#xD;
      The recordings of both T-reflex and WBV-IMR will be acquired using SEMG. SEMG data will be&#xD;
      recorded using a PowerLAB® data acquisition system (ADInstruments, Oxford, United Kingdom)&#xD;
      and the data will be analyzed offline using the LabChart7® (ver 7.3.7, ADInstruments, Oxford,&#xD;
      United Kingdom) software.&#xD;
&#xD;
      Precautions for voluntary muscle contractions and motion artifacts:&#xD;
&#xD;
        1. the participants will be asked to use the handles of the WBV device to secure their&#xD;
           balance. The sense of balance may impair during WBV. Therefore muscles may be activated&#xD;
           to restore balance during WBV,&#xD;
&#xD;
        2. before WBV trials, participants will be asked to relax and not to make voluntary&#xD;
           contractions in their lower extremity muscles.&#xD;
&#xD;
        3. a trial protocol will be applied to familiarize vibration,&#xD;
&#xD;
        4. all cables will be carefully taped to the skin to minimize motion artifacts,&#xD;
&#xD;
        5. all EMG recordings will be filtered to avoid WBV induced movement artifacts using a band&#xD;
           pass filter from 60 to 500 Hz.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">April 17, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 17, 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presynaptic Ia inhibition level</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Effects of Vibration</condition>
  <arm_group>
    <arm_group_label>WBV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>whole-body vibration (WBV) group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vibration</intervention_name>
    <description>Whole body vibration at 25Hz frequency</description>
    <arm_group_label>WBV group</arm_group_label>
    <other_name>Whole body vibration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male&#xD;
&#xD;
          -  Right-handed men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and&#xD;
             spine&#xD;
&#xD;
          -  Medication that could affect the musculoskeletal system&#xD;
&#xD;
          -  Postural abnormalities (scoliosis, kyphosis, etc)&#xD;
&#xD;
          -  Systemic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bagcilar Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ilhan Karacan, Clinical Associated Professor</investigator_full_name>
    <investigator_title>Head of PMR clinic</investigator_title>
  </responsible_party>
  <keyword>Whole body vibration</keyword>
  <keyword>Bone myoregulation reflex</keyword>
  <keyword>H-reflex</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/NCT03016286
org study id: BMR20171
nct id: NCT03016286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypotheses of this study are

        1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body
           vibration (WBV)

        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this
           study is to test these hypotheses.

      Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at
      35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20
      minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of
      the right ankle, and during WBV respectively.
Hypotheses of this study are

        1. Bone myoregulation reflex (BMR) inhibits presynaptically T-reflex during whole-body
           vibration (WBV)

        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus T-reflex Aim of this
           study is to test these hypotheses.

      Methods:

      Participants:

      Ten young, healthy and right hand dominant male adult volunteers will be included in this
      study.

      Procedure:

      Prior to the induction of WBV, control T-reflex recordings will be elicited and then the
      participants will complete a 15-s trial WBV protocol to familiarize themselves with the
      procedure. Following the control T-reflex recordings, the trial protocol and a 15-s rest, the
      participants will receive one session WBV. T-reflex will be recorded during WBV. Then, cold
      pack will be applied to the right ankle for 20 minutes. T-reflex will be recorded during the
      cooling of the ankle. Then, the participants will receive one session WBV, again. T-reflex
      will be recorded during WBV.

      A light (2.9 gr.) triaxial (x, y and z-axis) accelerometer (LIS344ALH, ECOPACK®) will be
      taped on the right Achilles tendon so that the z-axis will be perpendicular with the
      direction of the tendon (Achilles accelerometer). A custom-made reflex hammer will be used to
      tap the right Achilles tendon just caudal to the accelerometer. The intensity of tapping will
      be about 19.6 N WBV frequencies of 35 Hz will be delivered for 60 s. The vibration plate of
      WBV device (Power-Plate®Pro5, PowerPlate® International, Ltd. London, UK) oscillates with a
      linear movement upward and downward. The participants will be barefooted and stand directly
      on the vibration platform. The surface electromyography (SEMG) data will be obtained while
      the participants stand upright on the vibration platform with the knees in extension. The
      Ag/AgCl electrodes (KENDALL®Covidien) with a disc radius of 10 mm will be placed 20 mm apart
      on the right soleus muscle belly on shaved skin in accordance with the recommendations of the
      Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) project .

      The recordings of both T-reflex and WBV-IMR will be acquired using SEMG. SEMG data will be
      recorded using a PowerLAB® data acquisition system (ADInstruments, Oxford, United Kingdom)
      and the data will be analyzed offline using the LabChart7® (ver 7.3.7, ADInstruments, Oxford,
      United Kingdom) software.

      Precautions for voluntary muscle contractions and motion artifacts:

        1. the participants will be asked to use the handles of the WBV device to secure their
           balance. The sense of balance may impair during WBV. Therefore muscles may be activated
           to restore balance during WBV,

        2. before WBV trials, participants will be asked to relax and not to make voluntary
           contractions in their lower extremity muscles.

        3. a trial protocol will be applied to familiarize vibration,

        4. all cables will be carefully taped to the skin to minimize motion artifacts,

        5. all EMG recordings will be filtered to avoid WBV induced movement artifacts using a band
           pass filter from 60 to 500 Hz.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Presynaptic Ia inhibition level
time frame: 1 month
arm group label: WBV group
arm group type: Experimental
description: whole-body vibration (WBV) group
intervention type: Other
intervention name: vibration
description: Whole body vibration at 25Hz frequency
arm group label: WBV group
other name: Whole body vibration
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Bagcilar Training and Research Hospital
investigator full name: Ilhan Karacan, Clinical Associated Professor
investigator title: Head of PMR clinic
sharing ipd: No