<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/NCT03756831</url>
  </required_header>
  <id_info>
    <org_study_id>2378388561</org_study_id>
    <nct_id>NCT03756831</nct_id>
  </id_info>
  <brief_title>The Influence of BMI on Core Stability in Healthy Adults</brief_title>
  <official_title>The Influence of BMI on Core Stability in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wafaa Mahmoud Amin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Jazan</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 will be conducted to investigate the influence of body mass index (BMI) on core&#xD;
      stability (CS) in healthy subjects. The participants in this study will be 90 healthy&#xD;
      subjects with right dominant lower limb (49 females and 49 males) they will be recruited from&#xD;
      College of Applied Medical Sciences, Jazan University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be categorized according to BMI into three groups:&#xD;
&#xD;
      Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI&lt;25&#xD;
      kg//m^2)) Group II (overweight subjects): 30 individuals (15 male, and 15 female students)&#xD;
      with (BMI, 25-30 kg//m^2)).&#xD;
&#xD;
      Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI&gt;30&#xD;
      kg//m^2)).&#xD;
&#xD;
      Motor control element of CS will be investigated by assessing bilateral static balance with&#xD;
      open and close eye, right foot balance test, and dynamic balance test using Prokin System for&#xD;
      balance. Data of this study will be statistically analyzed by performing descriptive (Mean&#xD;
      and standard deviation) and inferential statistics (One way ANOVA, Unpaired T test) at level&#xD;
      of significance p=&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>3x3 factorial design, according to body mass index (Independent variable)subjects will be divided into three groups (Group I - normal subjects-BMI&lt;25 kg/m2, Group II -overweight subjects-BMI, 25-30 kg/m2), Group III -obese subjects- BMI&gt;30 kg/m2). Core stability (dependent variable) will be measured by three tests : bilateral static balance with open and close eye, uni-pedal static balance test, and dynamic balance test using Prokin System for balance</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Static balance test with eyes opened</measure>
    <time_frame>30 Seconds</time_frame>
    <description>After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes are opened.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Static balance test with eyes closed</measure>
    <time_frame>30 Seconds</time_frame>
    <description>After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes closed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unipedal static balance</measure>
    <time_frame>30 Seconds</time_frame>
    <description>It will be measured respectively on right foot with eyes are opened.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic (Equilibrium/ Disequilibrium test)</measure>
    <time_frame>60 Seconds</time_frame>
    <description>the subject will stand on right foot(dominant), and see some galleries that come against. The subject's scope is to enter into those galleries and to maintain the tilting board as firm as possible.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Balance; Distorted</condition>
  <arm_group>
    <arm_group_label>Group I (normal subjects)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 individuals (15 male, and 15 female students) with (BMI&lt;25 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (overweight subjects)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III (obese subjects)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 individuals (15 male, and 15 female students) (BMI&gt;30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Core Stability Assessment</intervention_name>
    <description>Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.</description>
    <arm_group_label>Group I (normal subjects)</arm_group_label>
    <arm_group_label>Group II (overweight subjects)</arm_group_label>
    <arm_group_label>Group III (obese subjects)</arm_group_label>
    <other_name>Balance Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects would not have any diseases of the central nervous system.&#xD;
&#xD;
          2. Subjects would not have any orthopedic disorders either of the trunk or the lower&#xD;
             limbs in the previous year.&#xD;
&#xD;
          3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li,&#xD;
             2012) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sign of foot pain, reduced tactile and thermal foot sensibility.&#xD;
&#xD;
          2. Peripheral neuropathy.&#xD;
&#xD;
          3. A history of previous back or abdominal surgery/injury&#xD;
&#xD;
          4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .&#xD;
&#xD;
          5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.&#xD;
&#xD;
          6. Evidence of a systemic or musculoskeletal disease within the past six months&#xD;
             (AlAbdulwahab &amp; Kachanathu, 2016).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jazan University</name>
      <address>
        <city>Riyadh</city>
        <state>Jazan</state>
        <zip>45142</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</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>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jazan</investigator_affiliation>
    <investigator_full_name>Wafaa Mahmoud Amin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>BMI, Core Stability, Healthy Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03756831
org study id: 2378388561
nct id: NCT03756831
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to investigate the influence of body mass index (BMI) on core
      stability (CS) in healthy subjects. The participants in this study will be 90 healthy
      subjects with right dominant lower limb (49 females and 49 males) they will be recruited from
      College of Applied Medical Sciences, Jazan University.
Subjects will be categorized according to BMI into three groups:

      Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI<25
      kg//m^2)) Group II (overweight subjects): 30 individuals (15 male, and 15 female students)
      with (BMI, 25-30 kg//m^2)).

      Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI>30
      kg//m^2)).

      Motor control element of CS will be investigated by assessing bilateral static balance with
      open and close eye, right foot balance test, and dynamic balance test using Prokin System for
      balance. Data of this study will be statistically analyzed by performing descriptive (Mean
      and standard deviation) and inferential statistics (One way ANOVA, Unpaired T test) at level
      of significance p=<0.05.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 3x3 factorial design, according to body mass index (Independent variable)subjects will be divided into three groups (Group I - normal subjects-BMI<25 kg/m2, Group II -overweight subjects-BMI, 25-30 kg/m2), Group III -obese subjects- BMI>30 kg/m2). Core stability (dependent variable) will be measured by three tests : bilateral static balance with open and close eye, uni-pedal static balance test, and dynamic balance test using Prokin System for balance
primary purpose: Diagnostic
masking: None (Open Label)
measure: Static balance test with eyes opened
time frame: 30 Seconds
description: After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes are opened.
measure: Static balance test with eyes closed
time frame: 30 Seconds
description: After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes closed.
measure: Unipedal static balance
time frame: 30 Seconds
description: It will be measured respectively on right foot with eyes are opened.
measure: Dynamic (Equilibrium/ Disequilibrium test)
time frame: 60 Seconds
description: the subject will stand on right foot(dominant), and see some galleries that come against. The subject's scope is to enter into those galleries and to maintain the tilting board as firm as possible.
arm group label: Group I (normal subjects)
arm group type: Active Comparator
description: 30 individuals (15 male, and 15 female students) with (BMI<25 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.
arm group label: Group II (overweight subjects)
arm group type: Active Comparator
description: 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.
arm group label: Group III (obese subjects)
arm group type: Active Comparator
description: 30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.
intervention type: Diagnostic Test
intervention name: Core Stability Assessment
description: Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
arm group label: Group I (normal subjects)
arm group label: Group II (overweight subjects)
arm group label: Group III (obese subjects)
other name: Balance Assessment
criteria: 
gender: All
minimum age: 19 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jazan
investigator full name: Wafaa Mahmoud Amin
investigator title: Principal Investigator
mesh term: Overweight
sharing ipd: Undecided