<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/NCT04415099</url>
  </required_header>
  <id_info>
    <org_study_id>LUT 12/46-16</org_study_id>
    <nct_id>NCT04415099</nct_id>
  </id_info>
  <brief_title>Tibialis Posterior Fatigue and Plantar Pressure</brief_title>
  <official_title>The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics</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>
      The purpose of this study is to find out the changes in the measurable parameters of the&#xD;
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is&#xD;
      activated by the fatigue protocol. The study includes 30 healthy patients whose&#xD;
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and&#xD;
      static position of foot were measured by pedobarography whereas the level of fatigue was&#xD;
      measured by Borg Fatigue Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to find out the changes in the measurable parameters of the&#xD;
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is&#xD;
      activated by the fatigue protocol. The study includes 30 healthy patients whose&#xD;
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and&#xD;
      static position of foot were measured by pedobarography whereas the level of fatigue was&#xD;
      measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to&#xD;
      determine the normality. The student's t-test for paired samples were used to analyse, means&#xD;
      (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's&#xD;
      d-effect size were calculated. The significance level was set at .05. The effect size was&#xD;
      considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plantar Pressures of the foot</measure>
    <time_frame>1 month</time_frame>
    <description>The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contact area of the foot</measure>
    <time_frame>1 month</time_frame>
    <description>The percentage of the contact area (CA%) of forefoot (FF), midfoot (MF) and hindfoot (HF) was recorded. The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot axis angle</measure>
    <time_frame>1 month</time_frame>
    <description>Foot axis angle (FAA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subtalar angle</measure>
    <time_frame>1 month</time_frame>
    <description>Minimum and maximum value of the subtalar angle (STA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static plantar pressure</measure>
    <time_frame>1 month</time_frame>
    <description>The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Muscle Fatigue</condition>
  <arm_group>
    <arm_group_label>One group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only one group was assessed before and after performing muscle fatigue protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle fatigue protocol</intervention_name>
    <description>Tibialis posterior was fatigued using 2 exercises:&#xD;
Unilateral heel raise exercise&#xD;
Close chain resisted foot adduction exercise</description>
    <arm_group_label>One group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants were currently free from congenital or traumatic deformity to either&#xD;
             lower extremity,&#xD;
&#xD;
          -  A history of foot pain,&#xD;
&#xD;
          -  Prior history of surgery to the foot and lower extremity&#xD;
&#xD;
          -  A traumatic injury to the ankle or foot 12 months prior to the start of data&#xD;
             collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants were excluded from this study if they had any orthopedic or neurological&#xD;
             disorder, need to use an assistive device or orthoses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilgün Bek, Prof.Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Lokman Hekim Üniversitesi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azize Reda Caferoglu Tunç, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lokman Hekim Üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pınar Kısacık</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Pınar Kısacık, PhD</investigator_full_name>
    <investigator_title>Research Assistant, PhD.</investigator_title>
  </responsible_party>
  <keyword>Plantar pressure distribution</keyword>
  <keyword>muscle fatigue</keyword>
  <keyword>tibialis posterior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415099
org study id: LUT 12/46-16
nct id: NCT04415099
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out the changes in the measurable parameters of the
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is
      activated by the fatigue protocol. The study includes 30 healthy patients whose
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and
      static position of foot were measured by pedobarography whereas the level of fatigue was
      measured by Borg Fatigue Scale.
The purpose of this study is to find out the changes in the measurable parameters of the
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is
      activated by the fatigue protocol. The study includes 30 healthy patients whose
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and
      static position of foot were measured by pedobarography whereas the level of fatigue was
      measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to
      determine the normality. The student's t-test for paired samples were used to analyse, means
      (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's
      d-effect size were calculated. The significance level was set at .05. The effect size was
      considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Peak Plantar Pressures of the foot
time frame: 1 month
description: The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
measure: Contact area of the foot
time frame: 1 month
description: The percentage of the contact area (CA%) of forefoot (FF), midfoot (MF) and hindfoot (HF) was recorded. The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
measure: Foot axis angle
time frame: 1 month
description: Foot axis angle (FAA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
measure: Subtalar angle
time frame: 1 month
description: Minimum and maximum value of the subtalar angle (STA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
measure: Static plantar pressure
time frame: 1 month
description: The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
arm group label: One group
arm group type: Experimental
description: Only one group was assessed before and after performing muscle fatigue protocol.
intervention type: Other
intervention name: Muscle fatigue protocol
description: Tibialis posterior was fatigued using 2 exercises:
Unilateral heel raise exercise
Close chain resisted foot adduction exercise
arm group label: One group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nilgün Bek, Prof.Dr.
role: Study Director
affiliation: Lokman Hekim Üniversitesi
last name: Azize Reda Caferoglu Tunç, MSc
role: Principal Investigator
affiliation: Lokman Hekim Üniversitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Pınar Kısacık, PhD
investigator title: Research Assistant, PhD.
mesh term: Fatigue