xml: <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/NCT06037746</url>
    </required_header>
    <id_info>
      <org_study_id>PP001</org_study_id>
      <nct_id>NCT06037746</nct_id>
    </id_info>
    <brief_title>Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus</brief_title>
    <official_title>Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus: A Single Blind, Randomized Controlled Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Gelisim University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Gelisim 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 plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends&#xD;
        along the plantar surface of the foot.The configuration of the plantar fascia is generally&#xD;
        considered as a dense, longitudinally arranged fiber band divided into medial, central, and&#xD;
        lateral components. The most significant functional role of the plantar fascia is to maintain&#xD;
        the arch structure of the foot, providing a stable support base while standing and absorbing&#xD;
        dynamic reaction forces during walking.Pes planus is a rather general term with many&#xD;
        definitions. Staheli described pes planus as a &quot;foot with a broad base of support,&quot; commonly&#xD;
        known as flatfoot in layman's terms. In a study involving 80 female participants aged 65 and&#xD;
        older, 90% of foot deformities observed while standing were identified as pes planus.&#xD;
        Generally, pes planus is a condition characterized by excessive pronation of the rear part of&#xD;
        the foot and a lowering of the medial longitudinal arch. During the push-off phase of&#xD;
        walking, the pronation moment generated by the ground reaction force flattens the arch as the&#xD;
        subtalar joint rotation combines. The shift in position in the talus bone causes the&#xD;
        navicular bone to drop. The plantar calcaneonavicular ligament tightens, and the tibialis&#xD;
        posterior muscle lengthens. Abnormalities in the bones of the foot, dysfunction of the&#xD;
        tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to&#xD;
        pes planus. Individuals with pes planus may experience foot and leg pain with exercise,&#xD;
        physical activity, and prolonged walking, which can limit their level of physical activity.&#xD;
        Research has examined the relationship between pes planus and various physical parameters,&#xD;
        and it has been found that one of these parameters, balance, is negatively affected by the&#xD;
        presence of pes planus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participant information, including age, gender, height, body weight, and body mass index, was&#xD;
        recorded using a general form. Dynamic and static balance was assessed before and after the&#xD;
        interventions in the study groups. Three specialist physiotherapists conducted measurements&#xD;
        and evaluations (navicular drop, static and dynamic balance). The assessing physiotherapist&#xD;
        remained consistent throughout, and they were unaware of the participant groups. An expert in&#xD;
        manual therapy administered the MRTs. Statistical analysis was performed by a separate&#xD;
        researcher uninvolved in the practical aspects of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 25, 2022</start_date>
    <completion_date type="Actual">March 25, 2023</completion_date>
    <primary_completion_date type="Actual">December 25, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Static Balance Test</measure>
      <time_frame>Baseline and after immediately after intervention</time_frame>
      <description>The static balance level of individuals was measured with the Flamingo Balance Test, a valid and reliable instrument. It was recorded how many times the individual fell or broke the test while trying to balance on one leg for 1 minute on a 15 cm long, 4 cm wide wooden plate. During this period, each time the test was stopped, the timer was also stopped, and the timer was restarted after the individual repositioned. The test was repeated 3 times, and the average value was recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic Balance Test</measure>
      <time_frame>Baseline and after immediately after intervention</time_frame>
      <description>The dynamic balance level of individuals was measured with the &quot;Y&quot; Balance Test, a valid and reliable instrument, and their dominant extremities were evaluated. While trying to balance on one foot at the midpoint of the assembly, the individual was asked to reach forward with the other foot in the anterior, posteromedial, and posterolateral directions and touch the tip of the toe. The test was repeated 3 times in each direction, and the average value was recorded.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Flat Foot</condition>
    <arm_group>
      <arm_group_label>Graston Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Miyofascial release was performed by graston tool on the entire plantar fascia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Percussive Massage Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Miyofascial release was performed by theragun tool on the entire plantar fascia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No application has been made.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Graston</intervention_name>
      <description>For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 10 minutes in the longitudinal, vertical and oblique directions.</description>
      <arm_group_label>Graston Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Percussive massage</intervention_name>
      <description>For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 5 minutes in all directions without being bound to a single direction.</description>
      <arm_group_label>Percussive Massage Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  volunteering for study participation,&#xD;
  &#xD;
            -  being between the ages of 18-25&#xD;
  &#xD;
            -  presence of pes planus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of orthopedic conditions other than pes planus,&#xD;
  &#xD;
            -  having a history of lower extremity surgery&#xD;
  &#xD;
            -  presence of neurological or rheumatological disorders,&#xD;
  &#xD;
            -  having a problem with vision or hearing&#xD;
  &#xD;
            -  participating in regular physical activity (&gt;150 min/week)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>İstanbul Gelisim University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pes Planus</keyword>
    <keyword>Myofascial Release</keyword>
    <keyword>Postural Balance</keyword>
    <keyword>Randomized Controlled Trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Flatfoot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>It is not yet known if there will be a plan to make IPD available.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037746
  org study id: PP001
  nct id: NCT06037746
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends
        along the plantar surface of the foot.The configuration of the plantar fascia is generally
        considered as a dense, longitudinally arranged fiber band divided into medial, central, and
        lateral components. The most significant functional role of the plantar fascia is to maintain
        the arch structure of the foot, providing a stable support base while standing and absorbing
        dynamic reaction forces during walking.Pes planus is a rather general term with many
        definitions. Staheli described pes planus as a "foot with a broad base of support," commonly
        known as flatfoot in layman's terms. In a study involving 80 female participants aged 65 and
        older, 90% of foot deformities observed while standing were identified as pes planus.
        Generally, pes planus is a condition characterized by excessive pronation of the rear part of
        the foot and a lowering of the medial longitudinal arch. During the push-off phase of
        walking, the pronation moment generated by the ground reaction force flattens the arch as the
        subtalar joint rotation combines. The shift in position in the talus bone causes the
        navicular bone to drop. The plantar calcaneonavicular ligament tightens, and the tibialis
        posterior muscle lengthens. Abnormalities in the bones of the foot, dysfunction of the
        tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to
        pes planus. Individuals with pes planus may experience foot and leg pain with exercise,
        physical activity, and prolonged walking, which can limit their level of physical activity.
        Research has examined the relationship between pes planus and various physical parameters,
        and it has been found that one of these parameters, balance, is negatively affected by the
        presence of pes planus.
  Participant information, including age, gender, height, body weight, and body mass index, was
        recorded using a general form. Dynamic and static balance was assessed before and after the
        interventions in the study groups. Three specialist physiotherapists conducted measurements
        and evaluations (navicular drop, static and dynamic balance). The assessing physiotherapist
        remained consistent throughout, and they were unaware of the participant groups. An expert in
        manual therapy administered the MRTs. Statistical analysis was performed by a separate
        researcher uninvolved in the practical aspects of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Static Balance Test
  time frame: Baseline and after immediately after intervention
  description: The static balance level of individuals was measured with the Flamingo Balance Test, a valid and reliable instrument. It was recorded how many times the individual fell or broke the test while trying to balance on one leg for 1 minute on a 15 cm long, 4 cm wide wooden plate. During this period, each time the test was stopped, the timer was also stopped, and the timer was restarted after the individual repositioned. The test was repeated 3 times, and the average value was recorded.
  measure: Dynamic Balance Test
  time frame: Baseline and after immediately after intervention
  description: The dynamic balance level of individuals was measured with the "Y" Balance Test, a valid and reliable instrument, and their dominant extremities were evaluated. While trying to balance on one foot at the midpoint of the assembly, the individual was asked to reach forward with the other foot in the anterior, posteromedial, and posterolateral directions and touch the tip of the toe. The test was repeated 3 times in each direction, and the average value was recorded.
  arm group label: Graston Group
  arm group type: Experimental
  description: Miyofascial release was performed by graston tool on the entire plantar fascia.
  arm group label: Percussive Massage Group
  arm group type: Experimental
  description: Miyofascial release was performed by theragun tool on the entire plantar fascia.
  arm group label: Control Group
  arm group type: No Intervention
  description: No application has been made.
  intervention type: Other
  intervention name: Graston
  description: For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 10 minutes in the longitudinal, vertical and oblique directions.
  arm group label: Graston Group
  intervention type: Other
  intervention name: Percussive massage
  description: For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 5 minutes in all directions without being bound to a single direction.
  arm group label: Percussive Massage Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Flatfoot
  sharing ipd: Undecided
  ipd description: It is not yet known if there will be a plan to make IPD available.