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/NCT05973708</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0411</org_study_id>
      <nct_id>NCT05973708</nct_id>
    </id_info>
    <brief_title>Comparative Effects of Clamshells and Frog Pump Exercises</brief_title>
    <official_title>Comparative Effects of Clamshells and Frog Pump Exercises on Gluteus Medius Strengthening and Lower Extremity Function in Runners With Iliotibial Band Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen&#xD;
        from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome&#xD;
        (ITBS) is the most common cause of lateral knee pain among athletes who are involved in&#xD;
        sports that require continuous running or repetitive knee flexion and extension. The&#xD;
        incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects&#xD;
        of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity&#xD;
        function in runners with iliotibial band syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board&#xD;
        Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of&#xD;
        32 subjects with age group between 18-30 years (males) will be taken. Data will be collected&#xD;
        from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An&#xD;
        informed consent will be taken. A total of 26 subjects will be selected by following&#xD;
        inclusion and exclusion criteria and will equally divided in to two groups by random number&#xD;
        generator table. Both the Groups will continue the conventional training with Group A will&#xD;
        receive clamshell Exercise, and Group B will receive frog pump exercise in their respective&#xD;
        training programs. Outcome measures will be measured at baseline and after 2 weeks. Data&#xD;
        analysis will be done by SPSS version 25.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 20, 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>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Manual Muscle Testing (MMT)</measure>
      <time_frame>upto 6th weeks</time_frame>
      <description>For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used.&#xD;
  Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists.&#xD;
  Grading Scale Range: 0 to 5 0 None No visible or palpable contraction&#xD;
  Trace Visible or palpable contraction with no motion&#xD;
  Poor Full ROM gravity eliminated&#xD;
  Fair Full ROM against gravity&#xD;
  Good Full ROM against gravity, moderate resistance&#xD;
  Normal Full ROM against gravity, maximum resistance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hip Outcome Score (HOS)</measure>
      <time_frame>upto 6th weeks</time_frame>
      <description>The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip.&#xD;
  The HOS is a patient-completed measure that consists of an &quot;Activities of Daily Living&quot; subscale (17 scored items) and a &quot;Sports&quot; subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower Extremity Functional Scale (LEFS)</measure>
      <time_frame>upto 6th weeks</time_frame>
      <description>The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity.&#xD;
  LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders.&#xD;
  The LEFS rating scale categories are: (1) &quot;extreme difficulty or unable to perform,&quot; (2) &quot;quite a bit of difficulty,&quot; (3) &quot;moderate difficulty,&quot; (4) &quot;a little bit of difficulty,&quot; and (5) &quot;no difficulty.&quot; LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Iliotibial Band Syndrome</condition>
    <arm_group>
      <arm_group_label>Group A: Clamshell Exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will be given frog pumps exercises in their regular training program.&#xD;
  These exercises are given as:&#xD;
  In (0-2) week ,2 sets 10 repetitions&#xD;
  In (2-4)week, 3 sets of 10 repetitions&#xD;
  In (4-6)week, 3 sets of 15 repetitions</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Frog Pump Exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will be given frog pumps exercises in their regular training program.&#xD;
  These exercises are given as:&#xD;
  In (0-2) week ,2 sets 10 repetitions&#xD;
  In (2-4)week, 3 sets of 10 repetitions&#xD;
  In (4-6)week, 3 sets of 15 repetitions</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clamshell Exercise</intervention_name>
      <description>Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.</description>
      <arm_group_label>Group A: Clamshell Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Frog pump exercise</intervention_name>
      <description>Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.</description>
      <arm_group_label>Group B: Frog Pump Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Age (18-30yrs)&#xD;
  &#xD;
                 -  Gender (Males)&#xD;
  &#xD;
                 -  Positive Ober's test&#xD;
  &#xD;
                 -  Positive Noble's compression test&#xD;
  &#xD;
                 -  Suffering pain from past 3 months&#xD;
  &#xD;
                 -  Running approximately 5km/week&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Osteoporosis&#xD;
  &#xD;
                 -  Previous knee trauma/surgery&#xD;
  &#xD;
                 -  Patellofemoral joint pain&#xD;
  &#xD;
                 -  Popliteus tendinitis&#xD;
  &#xD;
                 -  Lateral meniscal injure&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samrood Akram, Mphil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University,Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samrood Akram, MPhil</last_name>
      <phone>923324806143</phone>
      <email>samrood.akram@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samrood Akram, Mphil</last_name>
      <phone>923324806143</phone>
      <email>samrood.akram@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pakistan Sports Board</name>
        <address>
          <city>Lahore</city>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Samrood Akram, Mphil</last_name>
        <phone>923324806143</phone>
        <email>samrood.akram@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27.</citation>
      <PMID>35007886</PMID>
    </reference>
    <reference>
      <citation>Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002.</citation>
      <PMID>21665168</PMID>
    </reference>
    <reference>
      <citation>Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.</citation>
      <PMID>15864895</PMID>
    </reference>
    <reference>
      <citation>Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693.</citation>
      <PMID>20086621</PMID>
    </reference>
    <reference>
      <citation>McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.</citation>
      <PMID>32448384</PMID>
    </reference>
    <reference>
      <citation>Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.</citation>
      <PMID>15896092</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>gluteus medius</keyword>
    <keyword>pain</keyword>
    <keyword>iliotibial band syndrome</keyword>
    <keyword>strength</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Iliotibial Band Syndrome</mesh_term>
    </condition_browse>
    <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/NCT05973708
  org study id: REC/RCR & AHS/23/0411
  nct id: NCT05973708
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen
        from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome
        (ITBS) is the most common cause of lateral knee pain among athletes who are involved in
        sports that require continuous running or repetitive knee flexion and extension. The
        incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects
        of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity
        function in runners with iliotibial band syndrome.
  This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board
        Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of
        32 subjects with age group between 18-30 years (males) will be taken. Data will be collected
        from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An
        informed consent will be taken. A total of 26 subjects will be selected by following
        inclusion and exclusion criteria and will equally divided in to two groups by random number
        generator table. Both the Groups will continue the conventional training with Group A will
        receive clamshell Exercise, and Group B will receive frog pump exercise in their respective
        training programs. Outcome measures will be measured at baseline and after 2 weeks. Data
        analysis will be done by SPSS version 25.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Manual Muscle Testing (MMT)
  time frame: upto 6th weeks
  description: For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used.
  Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists.
  Grading Scale Range: 0 to 5 0 None No visible or palpable contraction
  Trace Visible or palpable contraction with no motion
  Poor Full ROM gravity eliminated
  Fair Full ROM against gravity
  Good Full ROM against gravity, moderate resistance
  Normal Full ROM against gravity, maximum resistance
  measure: Hip Outcome Score (HOS)
  time frame: upto 6th weeks
  description: The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip.
  The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
  measure: Lower Extremity Functional Scale (LEFS)
  time frame: upto 6th weeks
  description: The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity.
  LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders.
  The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
  arm group label: Group A: Clamshell Exercise
  arm group type: Active Comparator
  description: Group B will be given frog pumps exercises in their regular training program.
  These exercises are given as:
  In (0-2) week ,2 sets 10 repetitions
  In (2-4)week, 3 sets of 10 repetitions
  In (4-6)week, 3 sets of 15 repetitions
  arm group label: Group B: Frog Pump Exercise
  arm group type: Active Comparator
  description: Group B will be given frog pumps exercises in their regular training program.
  These exercises are given as:
  In (0-2) week ,2 sets 10 repetitions
  In (2-4)week, 3 sets of 10 repetitions
  In (4-6)week, 3 sets of 15 repetitions
  intervention type: Other
  intervention name: Clamshell Exercise
  description: Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.
  arm group label: Group A: Clamshell Exercise
  intervention type: Other
  intervention name: Frog pump exercise
  description: Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.
  arm group label: Group B: Frog Pump Exercise
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samrood Akram, Mphil
  role: Principal Investigator
  affiliation: Riphah International University,Lahore
  last name: Samrood Akram, MPhil
  phone: 923324806143
  email: samrood.akram@riphah.edu.pk
  last name: Samrood Akram, Mphil
  phone: 923324806143
  email: samrood.akram@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  citation: Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27.
  PMID: 35007886
  citation: Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002.
  PMID: 21665168
  citation: Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
  PMID: 15864895
  citation: Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693.
  PMID: 20086621
  citation: McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.
  PMID: 32448384
  citation: Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
  PMID: 15896092
  responsible party type: Sponsor
  mesh term: Syndrome
  mesh term: Iliotibial Band Syndrome
  sharing ipd: No