<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/NCT04457141</url>
  </required_header>
  <id_info>
    <org_study_id>19/570-E_TFM</org_study_id>
    <nct_id>NCT04457141</nct_id>
  </id_info>
  <brief_title>Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.</brief_title>
  <acronym>minimalwomen</acronym>
  <official_title>Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</source>
  <oversight_info>
    <has_dmc>Yes</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>
      JUSTIFICATION:&#xD;
&#xD;
      Urinary incontinence is highly prevalent among women who play high impact sports such as&#xD;
      running. that observed one of the possible reasons for this high prevalence is delayed&#xD;
      activation of the pelvic floor in relation to the abdominal muscles.&#xD;
&#xD;
      The use of minimalist shoes during the race produces changes in muscle and joint biomechanics&#xD;
      and efficiency in the race. However, to date no studies evaluating the influence of footwear&#xD;
      in the musculature of the pelvic floor during the race.&#xD;
&#xD;
      OBJECTIVE: Describe and compare the electromyographic activity of the muscles of the pelvic&#xD;
      floor and abdominal during the race with conventional shoes and minimalist.&#xD;
&#xD;
      DESIGN: cross-over study experimental, analytical and prospective. METHODOLOGY: conventional&#xD;
      and minimalist: 50 healthy young women, 6- randomly distributed in two groups will be&#xD;
      included to characterise the electromyographic activity of the pelvic floor muscles before&#xD;
      and during running at 6-9-11 km/h with the two types of running shoes.&#xD;
&#xD;
      A baseline assessment will be performed to confirm that the women meet the inclusion and&#xD;
      exclusion criteria. The ability to run a 10-minute treadmill at a speed of 6-9-11 km/h will&#xD;
      be assessed, as well as the ability to adequately contract the pelvic floor muscles.&#xD;
&#xD;
      The group of 50 women will initially run randomly with conventional running shoes or with&#xD;
      minimalist running shoes, and then, after a 10-minute washout period, will run with the other&#xD;
      type of running shoe, i.e. if a participant in the first phase used conventional running&#xD;
      shoes, she will run with a minimalist running shoe in the second phase.&#xD;
&#xD;
      The cadence of step, the range of movement of the femur and the EMG recording with&#xD;
      electromyographic sensors of the pelvic floor musculature (using an intravaginal probe of the&#xD;
      germproof brand), abdominal (internal and external oblique), spinal erectors and gluteus&#xD;
      (using a surface sensor) in relation to the cycling gait will be collected and recorded with&#xD;
      barographic sensors. The variables to be included in the electromyography for each muscle in&#xD;
      relation to the gait cycle will be: onset of activation, duration, intensity and synergy with&#xD;
      their corresponding standard deviation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Crossover Assignment</intervention_model>
    <intervention_model_description>randomized clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electrical activation of the pelvic floor musculature, abdominal, gluteus maximus and lumbar erectors during the race in nulliparous women with sneakers traditional and minimalist</measure>
    <time_frame>Basal, 0.5, 1.0, 1.5 minutes after the start of the test.</time_frame>
    <description>PeriformTM vaginal probe Will collect the EMG activity of the muscles of the pelvic also register with superficial electrodes EMG abdominal, gluteus maximus and lumbar erectors. Records are made in a single session with washout periods in accordance with previous studies that have collected the activity of the EMG activity PF during treadmill running different speeds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cadence and Range of motion in the sagittal plane of the femur during running at different speeds in nulliparous women with conventional and minimalist shoes.</measure>
    <time_frame>Basal, 0.5, 1.0, 1.5 minutes after the start of the test.</time_frame>
    <description>Collect of the spatial displacement of the lower limb by means of an accelerometer located in the EMG sensor during the treadmill race at different speeds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum voluntary contraction (MVIC), minimum peak, maximum peak and total average of the muscles of the sp, abdominal (LE), gluteus maximus and erectors during running at different speeds in nulliparous women with conventional shoes and minimalist</measure>
    <time_frame>Basal, 0.5, 1.0, 1.5 minutes after the start of the test.</time_frame>
    <description>PeriformTM vaginal probe Will collect the EMG activity of the muscles of the pelvic also register with superficial electrodes EMG abdominal, gluteus maximus and lumbar erectors. Records are made in a single session with washout periods in accordance with previous studies that have collected the activity of the EMG activity PF during treadmill running different speeds.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>first:shod ,second:minimalist shoes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The first group will race with conventional shoes and then minimalist shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9 km/h and 30 seconds at 11km/h.&#xD;
They have a washout period of 10 minutes between both interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>first:minimalist shoes ,second:shod</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The second group will race with minimalist shoes and then conventional shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9km/h and 30 seconds at 11km/h.&#xD;
They have a washout period of 10 minutes between both interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Effect of pelvic floor for the use of minimalist shoes versus shod in woman.</intervention_name>
    <description>Measure the activity of the pelvic floor and others muscles with EMG during treadmill running with different speeds and different shoes: minimalist and shod.</description>
    <arm_group_label>first:minimalist shoes ,second:shod</arm_group_label>
    <arm_group_label>first:shod ,second:minimalist shoes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 to 38 years.&#xD;
&#xD;
          -  Nulliparous.&#xD;
&#xD;
          -  Clinically healthy at the time of the study.&#xD;
&#xD;
          -  Physically able for the requirement of the race on tape.&#xD;
&#xD;
          -  Body Mass Index (BMI) 20-25 kg / m2&#xD;
&#xD;
          -  Having signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  urogynecological dysfunction.&#xD;
&#xD;
          -  Lower limb surgeries performed in the last six months.&#xD;
&#xD;
          -  Not be able to make voluntary contractions of the pelvic floor standardized according&#xD;
             to the Modified Oxford Scale&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Garcia</last_name>
    <role>Principal Investigator</role>
    <affiliation>universidad complutense</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Radiology, Rehabilitation and Physiotherapy</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic floor</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Barefoot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All the researchers will participate in all the study phases.</ipd_description>
  </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/NCT04457141
org study id: 19/570-E_TFM
nct id: NCT04457141
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
JUSTIFICATION:

      Urinary incontinence is highly prevalent among women who play high impact sports such as
      running. that observed one of the possible reasons for this high prevalence is delayed
      activation of the pelvic floor in relation to the abdominal muscles.

      The use of minimalist shoes during the race produces changes in muscle and joint biomechanics
      and efficiency in the race. However, to date no studies evaluating the influence of footwear
      in the musculature of the pelvic floor during the race.

      OBJECTIVE: Describe and compare the electromyographic activity of the muscles of the pelvic
      floor and abdominal during the race with conventional shoes and minimalist.

      DESIGN: cross-over study experimental, analytical and prospective. METHODOLOGY: conventional
      and minimalist: 50 healthy young women, 6- randomly distributed in two groups will be
      included to characterise the electromyographic activity of the pelvic floor muscles before
      and during running at 6-9-11 km/h with the two types of running shoes.

      A baseline assessment will be performed to confirm that the women meet the inclusion and
      exclusion criteria. The ability to run a 10-minute treadmill at a speed of 6-9-11 km/h will
      be assessed, as well as the ability to adequately contract the pelvic floor muscles.

      The group of 50 women will initially run randomly with conventional running shoes or with
      minimalist running shoes, and then, after a 10-minute washout period, will run with the other
      type of running shoe, i.e. if a participant in the first phase used conventional running
      shoes, she will run with a minimalist running shoe in the second phase.

      The cadence of step, the range of movement of the femur and the EMG recording with
      electromyographic sensors of the pelvic floor musculature (using an intravaginal probe of the
      germproof brand), abdominal (internal and external oblique), spinal erectors and gluteus
      (using a surface sensor) in relation to the cycling gait will be collected and recorded with
      barographic sensors. The variables to be included in the electromyography for each muscle in
      relation to the gait cycle will be: onset of activation, duration, intensity and synergy with
      their corresponding standard deviation.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized clinical trial
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Electrical activation of the pelvic floor musculature, abdominal, gluteus maximus and lumbar erectors during the race in nulliparous women with sneakers traditional and minimalist
time frame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
description: PeriformTM vaginal probe Will collect the EMG activity of the muscles of the pelvic also register with superficial electrodes EMG abdominal, gluteus maximus and lumbar erectors. Records are made in a single session with washout periods in accordance with previous studies that have collected the activity of the EMG activity PF during treadmill running different speeds.
measure: Cadence and Range of motion in the sagittal plane of the femur during running at different speeds in nulliparous women with conventional and minimalist shoes.
time frame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
description: Collect of the spatial displacement of the lower limb by means of an accelerometer located in the EMG sensor during the treadmill race at different speeds
measure: Maximum voluntary contraction (MVIC), minimum peak, maximum peak and total average of the muscles of the sp, abdominal (LE), gluteus maximus and erectors during running at different speeds in nulliparous women with conventional shoes and minimalist
time frame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
description: PeriformTM vaginal probe Will collect the EMG activity of the muscles of the pelvic also register with superficial electrodes EMG abdominal, gluteus maximus and lumbar erectors. Records are made in a single session with washout periods in accordance with previous studies that have collected the activity of the EMG activity PF during treadmill running different speeds.
arm group label: first:shod ,second:minimalist shoes
arm group type: Other
description: The first group will race with conventional shoes and then minimalist shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9 km/h and 30 seconds at 11km/h.
They have a washout period of 10 minutes between both interventions.
arm group label: first:minimalist shoes ,second:shod
arm group type: Other
description: The second group will race with minimalist shoes and then conventional shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9km/h and 30 seconds at 11km/h.
They have a washout period of 10 minutes between both interventions.
intervention type: Combination Product
intervention name: Effect of pelvic floor for the use of minimalist shoes versus shod in woman.
description: Measure the activity of the pelvic floor and others muscles with EMG during treadmill running with different speeds and different shoes: minimalist and shod.
arm group label: first:minimalist shoes ,second:shod
arm group label: first:shod ,second:minimalist shoes
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Garcia
role: Principal Investigator
affiliation: universidad complutense
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress
sharing ipd: No
ipd description: All the researchers will participate in all the study phases.