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/NCT06034704</url>
    </required_header>
    <id_info>
      <org_study_id>AIBU-FTR-OOP-1</org_study_id>
      <nct_id>NCT06034704</nct_id>
    </id_info>
    <brief_title>Plantar Fascia Release With Magnetic Fascia Ball</brief_title>
    <official_title>Investigation of the Effect of Plantar Fascia Release With Magnetic Fascia Ball on Hamstring and Lumbar Spine Flexibility</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abant Izzet Baysal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Abant Izzet Baysal 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>
        In this study, the effect of plantar fascia release with a magnetic fascial cork ball on&#xD;
        hamstring and lumbar extensor muscle elasticity will be investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of tools such as foam rollers or massage balls to resolve myofascial tension is&#xD;
        highly preferred by both therapists and patients. It is theorized that the sweeping pressure&#xD;
        generated during rolling causes the fascia to stretch and increase the range of motion. In&#xD;
        addition, the warming caused by the friction during rolling can dissolve the adhesions&#xD;
        between the fascial layers and restore the elasticity of the myofascial tissues. In addition&#xD;
        to similar mechanical effects, the use of cork balls with magnetic properties is becoming&#xD;
        increasingly common. Studies have shown that static magnetic magnets reduce pain, increase&#xD;
        microcirculation and oxygenation and cause changes in presynaptic membrane function. As far&#xD;
        as we know, there is no study examining the myofascial relaxation effect of magnetic balls in&#xD;
        the literature. Evaluating the clinical impact and efficacy of this device which allow the&#xD;
        person to perform self-massage might contribute the current literature. This study was&#xD;
        planned to evaluate the myofascial relaxation caused by two different fascial cork balls with&#xD;
        and without magnetic properties.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">September 30, 2021</completion_date>
    <primary_completion_date type="Actual">September 30, 2021</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Goniometric Measurement of Hamstring Flexibility</measure>
      <time_frame>Two times in one day (before intervention, immediately after intervention)</time_frame>
      <description>Individuals are positioned supine with the hip of the limb to be measured at 90 degrees. In this position, active knee extension is requested and the acute angle between the long axis of the femur and the long axis of the fibula is measured. The DrGonyometer (iOS) smart phone application, for which a validity and reliability study was conducted, was used for the measurement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sit and reach test</measure>
      <time_frame>Two times in one day (before intervention, immediately after intervention)</time_frame>
      <description>Individuals are placed in a long sitting position with their feet resting on the test battery (Figure 2) and knees in full extension. They are asked to reach forward on the wooden block by placing their hands on top of each other. In this position, the distance between the fingers of the hand and the point where the foot rests is measured and the previous values are recorded as negative and the following values as positive.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Flexibility</condition>
    <condition>Muscle Tightness</condition>
    <arm_group>
      <arm_group_label>Magnetic Fascial Ball</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the experimental group, a fascial ball made of cork containing 3 magnets of 0.15 tesla was used. The magnetic fascia ball diameter is 6 centimetres.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-Magnetic Fascial Ball</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In the placebo group, a fascial ball made of cork without magnets. The non-magnetic fascia ball diameter is 6 centimetres.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Plantar fascia self massage with a magnetic fascia ball</intervention_name>
      <description>Participants were asked to roll the magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.</description>
      <arm_group_label>Magnetic Fascial Ball</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Plantar fascia self massage with a non-magnetic fascia ball</intervention_name>
      <description>Participants were asked to roll the non-magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.</description>
      <arm_group_label>Non-Magnetic Fascial Ball</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having scored 3 or less according to the Beighton scoring system&#xD;
  &#xD;
            -  18-35 years old,&#xD;
  &#xD;
            -  Having asymptomatic&#xD;
  &#xD;
            -  Voluntary participation in the research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having Beighton score of 4 and above&#xD;
  &#xD;
            -  Having history of previous surgery&#xD;
  &#xD;
            -  Having diagnosed pathology of the lower extremities and lumbar region&#xD;
        </textblock>
      </criteria>
      <gender>Female</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>Ömer Osman PALA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bolu Abant İzzet Baysal Üniversitesi</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Health Sciences Bolu Abant İzzet Baysal University</name>
        <address>
          <city>Bolu</city>
          <zip>14300</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Abant Izzet Baysal University</investigator_affiliation>
      <investigator_full_name>Ömer Osman Pala</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Massage</keyword>
    <keyword>Hamstring Muscles</keyword>
    <keyword>Magnets</keyword>
    <keyword>Lumbar Fascia</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06034704
  org study id: AIBU-FTR-OOP-1
  nct id: NCT06034704
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the effect of plantar fascia release with a magnetic fascial cork ball on
        hamstring and lumbar extensor muscle elasticity will be investigated.
  The use of tools such as foam rollers or massage balls to resolve myofascial tension is
        highly preferred by both therapists and patients. It is theorized that the sweeping pressure
        generated during rolling causes the fascia to stretch and increase the range of motion. In
        addition, the warming caused by the friction during rolling can dissolve the adhesions
        between the fascial layers and restore the elasticity of the myofascial tissues. In addition
        to similar mechanical effects, the use of cork balls with magnetic properties is becoming
        increasingly common. Studies have shown that static magnetic magnets reduce pain, increase
        microcirculation and oxygenation and cause changes in presynaptic membrane function. As far
        as we know, there is no study examining the myofascial relaxation effect of magnetic balls in
        the literature. Evaluating the clinical impact and efficacy of this device which allow the
        person to perform self-massage might contribute the current literature. This study was
        planned to evaluate the myofascial relaxation caused by two different fascial cork balls with
        and without magnetic properties.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Goniometric Measurement of Hamstring Flexibility
  time frame: Two times in one day (before intervention, immediately after intervention)
  description: Individuals are positioned supine with the hip of the limb to be measured at 90 degrees. In this position, active knee extension is requested and the acute angle between the long axis of the femur and the long axis of the fibula is measured. The DrGonyometer (iOS) smart phone application, for which a validity and reliability study was conducted, was used for the measurement.
  measure: Sit and reach test
  time frame: Two times in one day (before intervention, immediately after intervention)
  description: Individuals are placed in a long sitting position with their feet resting on the test battery (Figure 2) and knees in full extension. They are asked to reach forward on the wooden block by placing their hands on top of each other. In this position, the distance between the fingers of the hand and the point where the foot rests is measured and the previous values are recorded as negative and the following values as positive.
  arm group label: Magnetic Fascial Ball
  arm group type: Experimental
  description: In the experimental group, a fascial ball made of cork containing 3 magnets of 0.15 tesla was used. The magnetic fascia ball diameter is 6 centimetres.
  arm group label: Non-Magnetic Fascial Ball
  arm group type: Placebo Comparator
  description: In the placebo group, a fascial ball made of cork without magnets. The non-magnetic fascia ball diameter is 6 centimetres.
  intervention type: Other
  intervention name: Plantar fascia self massage with a magnetic fascia ball
  description: Participants were asked to roll the magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.
  arm group label: Magnetic Fascial Ball
  intervention type: Other
  intervention name: Plantar fascia self massage with a non-magnetic fascia ball
  description: Participants were asked to roll the non-magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.
  arm group label: Non-Magnetic Fascial Ball
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ömer Osman PALA
  role: Principal Investigator
  affiliation: Bolu Abant İzzet Baysal Üniversitesi
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Abant Izzet Baysal University
  investigator full name: Ömer Osman Pala
  investigator title: Assistant Professor
  sharing ipd: No