<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/NCT04440878</url>
  </required_header>
  <id_info>
    <org_study_id>Kamile UZUN AKKAYA</org_study_id>
    <nct_id>NCT04440878</nct_id>
  </id_info>
  <brief_title>The Acute Effects of Different Stretching Techniques</brief_title>
  <official_title>The Acute Effects of Different Hamstring Muscle Stretching Techniques on Reducing Muscle Resistance to Movement by Ultrasound Elastography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuksek Ihtisas University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuksek Ihtisas 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 flexibility of the hamstring muscles is very important and many stretching methods are&#xD;
      applied on the hamstring muscles for reducing muscle resistance on movement. The objective of&#xD;
      this study was to investigate the acute effects of static stretching and the Mulligan&#xD;
      traction straight leg raise (TSLR) technique administered to the hamstring muscles on&#xD;
      reducing its resistance to movement by using ultrasound elastography in healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be included 22 healthy male volunteers. Static stretching will be administered&#xD;
      to the hamstring muscles in the first group and the Mulligan TSLR technique will be&#xD;
      administered on the same muscle in the second group. Active knee extension angles of the&#xD;
      individuals will be evaluated by a digital goniometer and muscle elasticity will be assessed&#xD;
      by ultrasound elastography.&#xD;
&#xD;
      Acute effects of Mulligan TSLR on reducing muscle resistance to movement will be evaluated by&#xD;
      ultrasound elastography for the first time in this study. In our study, it was planned to&#xD;
      examine the acute effects of static stretching and Mulligan TSLR techniques on reducing&#xD;
      muscle resistance to movement by ultrasound elastography in healthy individuals with&#xD;
      hamstring shortness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">July 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The evaluation of muscle flexibility</measure>
    <time_frame>Five minutes after the application</time_frame>
    <description>The evaluation of muscle flexibility will be made using the ultrasound elastography method by a radiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of motion (ROM)</measure>
    <time_frame>Five minutes after the application</time_frame>
    <description>Active knee extension angles of the individuals will be measured using a digital goniometer by a physiotherapist.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Muscle Stretching Exercises</condition>
  <condition>Hamstring Muscles</condition>
  <arm_group>
    <arm_group_label>Static stretching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Static stretching will be administered to the hamstring muscles in the first group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mulligan TSLR technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Mulligan TSLR technique will be administered on the same muscle in the second group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Static stretching</intervention_name>
    <description>Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 15 seconds of rest with 10 repetitions, and the individuals will be asked to participate in the exercise actively.</description>
    <arm_group_label>Static stretching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mulligan TSLR technique</intervention_name>
    <description>Mulligan TSLR will be applied by a physiotherapist in 3 repetitions with the patient in the supine position.</description>
    <arm_group_label>Mulligan TSLR technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with short hamstring muscles (active knee extension angle below 70&#xD;
             degree),&#xD;
&#xD;
          -  Without knee, hip, ankle, or waist pathology,&#xD;
&#xD;
          -  Who had not undergone any surgery on the lower extremity were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with musculoskeletal, neurological, or vestibular problems,&#xD;
&#xD;
          -  Bone pathologies,&#xD;
&#xD;
          -  Joint laxity,&#xD;
&#xD;
          -  Diabetes,&#xD;
&#xD;
          -  Metabolic syndrome,&#xD;
&#xD;
          -  Arthritic or inflammatory problems were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yuksek Ihtisas University</name>
      <address>
        <city>Ankara</city>
        <zip>06520</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Cini A, de Vasconcelos GS, Lima CS. Acute effect of different time periods of passive static stretching on the hamstring flexibility. J Back Musculoskelet Rehabil. 2017;30(2):241-246. doi: 10.3233/BMR-160740.</citation>
    <PMID>27472859</PMID>
  </reference>
  <reference>
    <citation>Kerkhoffs GM, van Es N, Wieldraaijer T, Sierevelt IN, Ekstrand J, van Dijk CN. Diagnosis and prognosis of acute hamstring injuries in athletes. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):500-9. doi: 10.1007/s00167-012-2055-x. Epub 2012 May 24.</citation>
    <PMID>22622781</PMID>
  </reference>
  <reference>
    <citation>Rancour J, Holmes CF, Cipriani DJ. The effects of intermittent stretching following a 4-week static stretching protocol: a randomized trial. J Strength Cond Res. 2009 Nov;23(8):2217-22. doi: 10.1519/JSC.0b013e3181b869c7.</citation>
    <PMID>19826305</PMID>
  </reference>
  <reference>
    <citation>Yildirim MS, Ozyurek S, Tosun O, Uzer S, Gelecek N. Comparison of effects of static, proprioceptive neuromuscular facilitation and Mulligan stretching on hip flexion range of motion: a randomized controlled trial. Biol Sport. 2016 Mar;33(1):89-94. doi: 10.5604/20831862.1194126. Epub 2016 Feb 8.</citation>
    <PMID>26929476</PMID>
  </reference>
  <reference>
    <citation>Umegaki H, Ikezoe T, Nakamura M, Nishishita S, Kobayashi T, Fujita K, Tanaka H, Ichihashi N. Acute effects of static stretching on the hamstrings using shear elastic modulus determined by ultrasound shear wave elastography: Differences in flexibility between hamstring muscle components. Man Ther. 2015 Aug;20(4):610-3. doi: 10.1016/j.math.2015.02.006. Epub 2015 Mar 2.</citation>
    <PMID>25795108</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuksek Ihtisas University</investigator_affiliation>
    <investigator_full_name>Kamile UZUN AKKAYA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hamstrings</keyword>
  <keyword>Stretching exercises</keyword>
  <keyword>Ultrasound elastography</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04440878
org study id: Kamile UZUN AKKAYA
nct id: NCT04440878
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The flexibility of the hamstring muscles is very important and many stretching methods are
      applied on the hamstring muscles for reducing muscle resistance on movement. The objective of
      this study was to investigate the acute effects of static stretching and the Mulligan
      traction straight leg raise (TSLR) technique administered to the hamstring muscles on
      reducing its resistance to movement by using ultrasound elastography in healthy individuals.
The study will be included 22 healthy male volunteers. Static stretching will be administered
      to the hamstring muscles in the first group and the Mulligan TSLR technique will be
      administered on the same muscle in the second group. Active knee extension angles of the
      individuals will be evaluated by a digital goniometer and muscle elasticity will be assessed
      by ultrasound elastography.

      Acute effects of Mulligan TSLR on reducing muscle resistance to movement will be evaluated by
      ultrasound elastography for the first time in this study. In our study, it was planned to
      examine the acute effects of static stretching and Mulligan TSLR techniques on reducing
      muscle resistance to movement by ultrasound elastography in healthy individuals with
      hamstring shortness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The evaluation of muscle flexibility
time frame: Five minutes after the application
description: The evaluation of muscle flexibility will be made using the ultrasound elastography method by a radiologist.
measure: Range of motion (ROM)
time frame: Five minutes after the application
description: Active knee extension angles of the individuals will be measured using a digital goniometer by a physiotherapist.
arm group label: Static stretching
arm group type: Experimental
description: Static stretching will be administered to the hamstring muscles in the first group.
arm group label: Mulligan TSLR technique
arm group type: Experimental
description: The Mulligan TSLR technique will be administered on the same muscle in the second group.
intervention type: Behavioral
intervention name: Static stretching
description: Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 15 seconds of rest with 10 repetitions, and the individuals will be asked to participate in the exercise actively.
arm group label: Static stretching
intervention type: Behavioral
intervention name: Mulligan TSLR technique
description: Mulligan TSLR will be applied by a physiotherapist in 3 repetitions with the patient in the supine position.
arm group label: Mulligan TSLR technique
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Cini A, de Vasconcelos GS, Lima CS. Acute effect of different time periods of passive static stretching on the hamstring flexibility. J Back Musculoskelet Rehabil. 2017;30(2):241-246. doi: 10.3233/BMR-160740.
PMID: 27472859
citation: Kerkhoffs GM, van Es N, Wieldraaijer T, Sierevelt IN, Ekstrand J, van Dijk CN. Diagnosis and prognosis of acute hamstring injuries in athletes. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):500-9. doi: 10.1007/s00167-012-2055-x. Epub 2012 May 24.
PMID: 22622781
citation: Rancour J, Holmes CF, Cipriani DJ. The effects of intermittent stretching following a 4-week static stretching protocol: a randomized trial. J Strength Cond Res. 2009 Nov;23(8):2217-22. doi: 10.1519/JSC.0b013e3181b869c7.
PMID: 19826305
citation: Yildirim MS, Ozyurek S, Tosun O, Uzer S, Gelecek N. Comparison of effects of static, proprioceptive neuromuscular facilitation and Mulligan stretching on hip flexion range of motion: a randomized controlled trial. Biol Sport. 2016 Mar;33(1):89-94. doi: 10.5604/20831862.1194126. Epub 2016 Feb 8.
PMID: 26929476
citation: Umegaki H, Ikezoe T, Nakamura M, Nishishita S, Kobayashi T, Fujita K, Tanaka H, Ichihashi N. Acute effects of static stretching on the hamstrings using shear elastic modulus determined by ultrasound shear wave elastography: Differences in flexibility between hamstring muscle components. Man Ther. 2015 Aug;20(4):610-3. doi: 10.1016/j.math.2015.02.006. Epub 2015 Mar 2.
PMID: 25795108
responsible party type: Principal Investigator
investigator affiliation: Yuksek Ihtisas University
investigator full name: Kamile UZUN AKKAYA
investigator title: Principal Investigator
sharing ipd: Undecided