<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/NCT03791047</url>
  </required_header>
  <id_info>
    <org_study_id>GO 18/506</org_study_id>
    <nct_id>NCT03791047</nct_id>
  </id_info>
  <brief_title>Evaluation of Muscle Thickness and Balance in Young and Older Adults</brief_title>
  <official_title>The Relationship Between Muscle Thickness and Dynamic Balance in Young and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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>
      This study evaluates muscle thickness of trunk and lower limb and balance in young and older&#xD;
      healthy adults. The participants will be evaluated muscle thickness for 14 different muscle&#xD;
      and balance which evaluated by computerized force plate system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aging had an adverse affect on musculoskeletal system and balance parameters. Decreased&#xD;
      muscle strength or thickness negatively affect person's balance control. But there are no&#xD;
      information in the literature about the relationships between muscle thickness and balance in&#xD;
      healthy subjects. In addition to, it is not known which muscle responsible for balance.&#xD;
      Therefore, this study will evaluate muscle thickness via ultrasonography and balance in young&#xD;
      and older adults. Balance will be evaluated computerized Balance system. Muscle thickness for&#xD;
      different 14 muscle ( diaphragm, transversus abdominis,multifidus, longissimus, quadratus&#xD;
      lumborum, rectus abdominis, external and internal obliques, rectus femoris, vastus&#xD;
      intermedius, vastus lateralis, tibialis anterior, gastrocnemius, soleus) will be evaluated by&#xD;
      ultrasonography at the right side. Only diaphram muscle will be evaluated both right and left&#xD;
      side.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Limits of Stability</measure>
    <time_frame>15 minutes</time_frame>
    <description>Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle thickness</measure>
    <time_frame>30 minutes</time_frame>
    <description>Muscle thickness in millimeters by Ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural Sway</measure>
    <time_frame>15 minutes</time_frame>
    <description>Postural sway in centimeters by computerized balance system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>15 minutes</time_frame>
    <description>Fear of Falling will be evaluated by Fall Efficacy Scale - International is a questionnaire that assesses fear of falling. The total scores range from 16 &quot;absence of concern&quot; to 64 &quot;extreme concern.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint position sense</measure>
    <time_frame>15 minutes</time_frame>
    <description>Knee joint position sense test will be evaluated using an isokinetic dynamometer. The testing included passive positioning performed by the assessor and active-repositioning performed by the participants. As the difference between the target degree and the degree is increased, the sense of position worsens.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Healthy</condition>
  <condition>Balance; Distorted</condition>
  <arm_group>
    <arm_group_label>Experimental Group: Balance analysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sixty older subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group:Balance Analysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sixty young subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance Analysis</intervention_name>
    <description>Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.</description>
    <arm_group_label>Control Group:Balance Analysis</arm_group_label>
    <arm_group_label>Experimental Group: Balance analysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria For Young Adults:&#xD;
&#xD;
          -  To be a volunteer to participate&#xD;
&#xD;
          -  to be an aged 18-40 years old.&#xD;
&#xD;
        Inclusion Criteria For Older Adults:&#xD;
&#xD;
          -  To be a volunteer to participate&#xD;
&#xD;
          -  to be an aged 65-90 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Walking with assist device&#xD;
&#xD;
          -  Having a visual deficits&#xD;
&#xD;
          -  Having an orthopedic problems that affect balance&#xD;
&#xD;
          -  Having a neurological disorders&#xD;
&#xD;
          -  Having a musculoskeletal disorders that affect balance&#xD;
&#xD;
          -  Having an undergone orthopedic surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozden Ozkal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ozden Ozkal</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 10, 2019</last_update_submitted>
  <last_update_submitted_qc>March 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ozden Ozkal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Balance</keyword>
  <keyword>Postural control</keyword>
  <keyword>Muscle</keyword>
  <keyword>Older adults</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/NCT03791047
org study id: GO 18/506
nct id: NCT03791047
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates muscle thickness of trunk and lower limb and balance in young and older
      healthy adults. The participants will be evaluated muscle thickness for 14 different muscle
      and balance which evaluated by computerized force plate system.
Aging had an adverse affect on musculoskeletal system and balance parameters. Decreased
      muscle strength or thickness negatively affect person's balance control. But there are no
      information in the literature about the relationships between muscle thickness and balance in
      healthy subjects. In addition to, it is not known which muscle responsible for balance.
      Therefore, this study will evaluate muscle thickness via ultrasonography and balance in young
      and older adults. Balance will be evaluated computerized Balance system. Muscle thickness for
      different 14 muscle ( diaphragm, transversus abdominis,multifidus, longissimus, quadratus
      lumborum, rectus abdominis, external and internal obliques, rectus femoris, vastus
      intermedius, vastus lateralis, tibialis anterior, gastrocnemius, soleus) will be evaluated by
      ultrasonography at the right side. Only diaphram muscle will be evaluated both right and left
      side.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Limits of Stability
time frame: 15 minutes
description: Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.
measure: Muscle thickness
time frame: 30 minutes
description: Muscle thickness in millimeters by Ultrasound
measure: Postural Sway
time frame: 15 minutes
description: Postural sway in centimeters by computerized balance system
measure: Fear of falling
time frame: 15 minutes
description: Fear of Falling will be evaluated by Fall Efficacy Scale - International is a questionnaire that assesses fear of falling. The total scores range from 16 "absence of concern" to 64 "extreme concern.
measure: Joint position sense
time frame: 15 minutes
description: Knee joint position sense test will be evaluated using an isokinetic dynamometer. The testing included passive positioning performed by the assessor and active-repositioning performed by the participants. As the difference between the target degree and the degree is increased, the sense of position worsens.
arm group label: Experimental Group: Balance analysis
arm group type: Experimental
description: Sixty older subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.
arm group label: Control Group:Balance Analysis
arm group type: Active Comparator
description: Sixty young subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.
intervention type: Other
intervention name: Balance Analysis
description: Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
arm group label: Control Group:Balance Analysis
arm group label: Experimental Group: Balance analysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ozden Ozkal
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ozden Ozkal
investigator title: Principal Investigator
sharing ipd: No