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/NCT05981027</url>
    </required_header>
    <id_info>
      <org_study_id>SuleymanDUtahirkeskin03</org_study_id>
      <nct_id>NCT05981027</nct_id>
    </id_info>
    <brief_title>Static Stretching Exercises and Ultrasound Elastography Evaluation</brief_title>
    <official_title>Acute Effects of Static Stretching Exercises and the Mulligan Bent Leg Raise Technique on Hamstring Muscle Stiffness: an Ultrasound Elastography Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suleyman Demirel University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suleyman Demirel University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of thid study was to compare two methods applied to increase the flexibility of the&#xD;
        hamstring muscles and objectively evaluate changes in muscle stiffness using the&#xD;
        two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young&#xD;
        individuals with hamstring shortness were divided into two groups by simple randomization.&#xD;
        The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive&#xD;
        static stretching exercises to the second group. Hamstring flexibility was evaluated with the&#xD;
        sit-and-reach test, and muscle stiffness with the 2D SWE method.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2023</start_date>
    <completion_date type="Actual">May 10, 2023</completion_date>
    <primary_completion_date type="Actual">April 10, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Back-saver sit-and-reach test</measure>
      <time_frame>Up to 2 months</time_frame>
      <description>The difference between the back-saver sit-and-reach test and the classical sit-and-reach test is that the former is applied unilaterally. The test was administered using the sit-and-reach test box. The participants were asked to sit on a flat surface and rest the sole of one of their feet flat on the end of the box while keeping the other leg flat on the floor by flexing the knee and hips to 90° and 45° sequentially. Maintaining this position, they were asked to place one hand on the other with their palms facing down, slide their hands on the measuring board, slowly reach forward, wait for a second or two at the last point reached</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Two-dimensional Shear Wave Elastography</measure>
      <time_frame>Up to 2 months</time_frame>
      <description>All 2D SWE examinations were performed by a specialist radiologist using the Philips EPIQ-7 (EPIQ Elite Diagnostic Ultrasound System Release 7.0.5 Philips) device with an 18-4 MHz linear probe. These measurements were made with the patient lying in the prone position, with the knees in full extension, the ankle at the end of the stretcher, and the feet hanging down. The probe was placed longitudinally in the middle 1/3 of the hamstring muscles. The participants were asked to keep their muscles in a relaxed position, and no extra pressure was applied to the probe to avoid tissue compression that could artificially affect the measured tissue stiffness</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Hamstring Muscle</condition>
    <condition>Muscle Stretching Exercise</condition>
    <condition>Elastography</condition>
    <arm_group>
      <arm_group_label>Mulligan bent leg raise technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single session of 3 repetitions of Mulligan bent leg raise was applied to the participants.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Static stretching exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single session of 5 repetitive stretching exercises was performed on the participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mulligan bent leg raise technique</intervention_name>
      <description>In this study, while the participant was lying on his back on a high bed, the physiotherapist sat on the lateral side of the leg to be treated, placing the popliteal fossa of the participant's knee on his shoulder. The hip and knee of the leg to be stretched were placed in 90° flexion. Distraction was applied to the lower end of the femur, and the participant was asked to push the physiotherapist's shoulder with his leg and then relax. At this relaxation point, the physiotherapist pushed the flexed knee as far as possible in the direction of the ipsilateral shoulder in a painless range.</description>
      <arm_group_label>Mulligan bent leg raise technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Static stretching exercise</intervention_name>
      <description>The participant lay on a stretcher in the supine position with his back straight. The physiotherapist placed the participant's leg on his shoulder with the knee in full extension and supported by the ankle and flexed the hip as much as possible until a tension was felt in the posterior thigh. This position was maintained for 30 seconds.</description>
      <arm_group_label>Static stretching exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a limitation of more than 25° in the active knee extension test&#xD;
  &#xD;
            -  Only engaged in recreational sports during the study period&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a history of lower extremity injury within the last two years&#xD;
  &#xD;
            -  Not volunteering to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Süleyman Demirel Üniversitesi</name>
        <address>
          <city>Isparta</city>
          <state>Merkez</state>
          <zip>32200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Suleyman Demirel University</investigator_affiliation>
      <investigator_full_name>Tahir Keskin , Pt, MSc</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <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/NCT05981027
  org study id: SuleymanDUtahirkeskin03
  nct id: NCT05981027
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of thid study was to compare two methods applied to increase the flexibility of the
        hamstring muscles and objectively evaluate changes in muscle stiffness using the
        two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young
        individuals with hamstring shortness were divided into two groups by simple randomization.
        The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive
        static stretching exercises to the second group. Hamstring flexibility was evaluated with the
        sit-and-reach test, and muscle stiffness with the 2D SWE method.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Back-saver sit-and-reach test
  time frame: Up to 2 months
  description: The difference between the back-saver sit-and-reach test and the classical sit-and-reach test is that the former is applied unilaterally. The test was administered using the sit-and-reach test box. The participants were asked to sit on a flat surface and rest the sole of one of their feet flat on the end of the box while keeping the other leg flat on the floor by flexing the knee and hips to 90° and 45° sequentially. Maintaining this position, they were asked to place one hand on the other with their palms facing down, slide their hands on the measuring board, slowly reach forward, wait for a second or two at the last point reached
  measure: Two-dimensional Shear Wave Elastography
  time frame: Up to 2 months
  description: All 2D SWE examinations were performed by a specialist radiologist using the Philips EPIQ-7 (EPIQ Elite Diagnostic Ultrasound System Release 7.0.5 Philips) device with an 18-4 MHz linear probe. These measurements were made with the patient lying in the prone position, with the knees in full extension, the ankle at the end of the stretcher, and the feet hanging down. The probe was placed longitudinally in the middle 1/3 of the hamstring muscles. The participants were asked to keep their muscles in a relaxed position, and no extra pressure was applied to the probe to avoid tissue compression that could artificially affect the measured tissue stiffness
  arm group label: Mulligan bent leg raise technique
  arm group type: Experimental
  description: A single session of 3 repetitions of Mulligan bent leg raise was applied to the participants.
  arm group label: Static stretching exercise
  arm group type: Experimental
  description: A single session of 5 repetitive stretching exercises was performed on the participants.
  intervention type: Other
  intervention name: Mulligan bent leg raise technique
  description: In this study, while the participant was lying on his back on a high bed, the physiotherapist sat on the lateral side of the leg to be treated, placing the popliteal fossa of the participant's knee on his shoulder. The hip and knee of the leg to be stretched were placed in 90° flexion. Distraction was applied to the lower end of the femur, and the participant was asked to push the physiotherapist's shoulder with his leg and then relax. At this relaxation point, the physiotherapist pushed the flexed knee as far as possible in the direction of the ipsilateral shoulder in a painless range.
  arm group label: Mulligan bent leg raise technique
  intervention type: Other
  intervention name: Static stretching exercise
  description: The participant lay on a stretcher in the supine position with his back straight. The physiotherapist placed the participant's leg on his shoulder with the knee in full extension and supported by the ankle and flexed the hip as much as possible until a tension was felt in the posterior thigh. This position was maintained for 30 seconds.
  arm group label: Static stretching exercise
  criteria: 
  gender: Male
  minimum age: 20 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Suleyman Demirel University
  investigator full name: Tahir Keskin , Pt, MSc
  investigator title: Research Assistant
  sharing ipd: No