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/NCT05973695</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0128 UMIA</org_study_id>
      <nct_id>NCT05973695</nct_id>
    </id_info>
    <brief_title>Effects of Clamshell Versus Gluteal Bridge Exercises</brief_title>
    <official_title>Effects of Clamshell Versus Gluteal Bridge Exercises on Low Back Pain, Gluteal Strength and Disability Due to Prolonged Sitting in Females With Gluteal Amnesia</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>
        Gluteal amnesia is a &quot;condition&quot; where the individual is believed to have lost the ability to&#xD;
        contract their gluteal muscles - generally the gluteus maximus, though some report it as the&#xD;
        gluteus medius. This can take many different names, such as &quot;dead butt&quot;, &quot;sleeping glutes&quot;,&#xD;
        or glutes that are &quot;turned off&quot;.Since the gluteus medius normally helps stabilize the pelvis,&#xD;
        gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues,&#xD;
        as the body tries to compensate for the imbalance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A Randomized controlled trial will be conducted at Jinnah Hospital Physiotherapy Clinic &amp;&#xD;
        Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32&#xD;
        patients which will be allocated through simple random sampling through sealed opaque&#xD;
        enveloped into group A &amp; group B. Group A will be treated with clamshell exercises at the&#xD;
        frequency of 3 sets with 10 repetitions 3 times/ week with baseline treatment. Group B will&#xD;
        be treated with gluteal bridge and baseline treatment. Baseline treatment for both groups&#xD;
        will be given Hot pack at low back for 10 minutes and Quadriceps and hamstring stretching 3&#xD;
        times with 30 seconds hold. Outcome measures will be conducted through pain, disability and&#xD;
        quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software&#xD;
        version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided&#xD;
        either parametric or non-parametric test will be used within a group or between two groups.&#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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numerical Pain Rating scale (NPRS)</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>The numerical Pain Rating scale (NPRS) assesses the pain in the gluteal region.&#xD;
  Pain is assessed using a Numeric pain rating (NPRS). The scale ranges from 0 to 10. 0 indicates &quot;no pain&quot;, and 10 indicates &quot;worst Pain.&#xD;
  mild pain score 1 to 3 moderate pain score 4 to 7 severe pain score with interference with functioning. 8 to 10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oswestry disability score</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>Oswestry Disability score is used to measure low back disability.&#xD;
  Each ten item is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP.&#xD;
  Oswestry Disability Index will evaluate disability for disability. This questionnaire will be used to assess disability. It comprises 10 items, 7 related to daily activities, 2 related to pain, and 1 related to concentration. Each item scores from 0 to 5. The total score is expressed as a percentage with higher scores related to more significant disability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life EQ-5D</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>EQ-5D Health-Related Quality of Life Question checked the quality of life of the patients.&#xD;
  Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain &amp; discomfort, Anxiety &amp; depression), each with five severity levels described by statements appropriate to that dimension.&#xD;
  The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Lower Crossed Syndrome</condition>
    <arm_group>
      <arm_group_label>Group A: Clamshell Exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A will be treated with baseline treatment and clamshell exercises. Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Gluteal Bridge exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will be treated with baseline treatment and Gluteal Bridge exercises. Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive down through your feet and push your hips up. You should feel this variation fatiguing the outer portion of your thighs. Make sure you keep your knees over your toes throughout the entire movement. Don't let them move forward over the toes. In a controlled motion, let your hips sink back down toward the ground. This completes 1 repetition. Perform 3 sets of 15 repetitions, or 3 rounds of a 30-second hold.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>clamshell exercise</intervention_name>
      <description>For clamshell exercises, Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions</description>
      <arm_group_label>Group A: Clamshell Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gluteal Bridge exercises</intervention_name>
      <description>Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive d</description>
      <arm_group_label>Group B: Gluteal Bridge exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Female between the ages of 20 to 40 years&#xD;
  &#xD;
                 -  Prolonged sitting hours &gt;4 hours.&#xD;
  &#xD;
                 -  Examination- Symptoms provoked by low back movement.&#xD;
  &#xD;
                 -  Positive Gluteal strength test&#xD;
  &#xD;
                 -  Positive SLR for hamstring tightness&#xD;
  &#xD;
                 -  Positive Thomas test for Rectus femoris tightness.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Osteoporosis&#xD;
  &#xD;
                 -  Malignancy&#xD;
  &#xD;
                 -  Vertebral fractures&#xD;
  &#xD;
                 -  Pervious or scheduled surgery&#xD;
  &#xD;
                 -  Trauma&#xD;
  &#xD;
                 -  Pregnancy&#xD;
  &#xD;
                 -  Psychological conditions&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 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>Jinnah hospital</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <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>
    <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>gluteal weakness</keyword>
    <keyword>disability</keyword>
    <keyword>pain</keyword>
    <keyword>gluteal amnesia</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/NCT05973695
  org study id: REC/RCR & AHS/23/0128 UMIA
  nct id: NCT05973695
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to
        contract their gluteal muscles - generally the gluteus maximus, though some report it as the
        gluteus medius. This can take many different names, such as "dead butt", "sleeping glutes",
        or glutes that are "turned off".Since the gluteus medius normally helps stabilize the pelvis,
        gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues,
        as the body tries to compensate for the imbalance.
  A Randomized controlled trial will be conducted at Jinnah Hospital Physiotherapy Clinic &
        Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32
        patients which will be allocated through simple random sampling through sealed opaque
        enveloped into group A & group B. Group A will be treated with clamshell exercises at the
        frequency of 3 sets with 10 repetitions 3 times/ week with baseline treatment. Group B will
        be treated with gluteal bridge and baseline treatment. Baseline treatment for both groups
        will be given Hot pack at low back for 10 minutes and Quadriceps and hamstring stretching 3
        times with 30 seconds hold. Outcome measures will be conducted through pain, disability and
        quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software
        version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided
        either parametric or non-parametric test will be used within a group or between two groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Numerical Pain Rating scale (NPRS)
  time frame: upto 4 weeks
  description: The numerical Pain Rating scale (NPRS) assesses the pain in the gluteal region.
  Pain is assessed using a Numeric pain rating (NPRS). The scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst Pain.
  mild pain score 1 to 3 moderate pain score 4 to 7 severe pain score with interference with functioning. 8 to 10
  measure: Oswestry disability score
  time frame: upto 4 weeks
  description: Oswestry Disability score is used to measure low back disability.
  Each ten item is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP.
  Oswestry Disability Index will evaluate disability for disability. This questionnaire will be used to assess disability. It comprises 10 items, 7 related to daily activities, 2 related to pain, and 1 related to concentration. Each item scores from 0 to 5. The total score is expressed as a percentage with higher scores related to more significant disability
  measure: Quality of Life EQ-5D
  time frame: upto 4 weeks
  description: EQ-5D Health-Related Quality of Life Question checked the quality of life of the patients.
  Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each with five severity levels described by statements appropriate to that dimension.
  The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.
  arm group label: Group A: Clamshell Exercise
  arm group type: Active Comparator
  description: Group A will be treated with baseline treatment and clamshell exercises. Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions.
  arm group label: Group B: Gluteal Bridge exercise
  arm group type: Active Comparator
  description: Group B will be treated with baseline treatment and Gluteal Bridge exercises. Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive down through your feet and push your hips up. You should feel this variation fatiguing the outer portion of your thighs. Make sure you keep your knees over your toes throughout the entire movement. Don't let them move forward over the toes. In a controlled motion, let your hips sink back down toward the ground. This completes 1 repetition. Perform 3 sets of 15 repetitions, or 3 rounds of a 30-second hold.
  intervention type: Other
  intervention name: clamshell exercise
  description: For clamshell exercises, Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions
  arm group label: Group A: Clamshell Exercise
  intervention type: Other
  intervention name: Gluteal Bridge exercises
  description: Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive d
  arm group label: Group B: Gluteal Bridge exercise
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 40 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
  responsible party type: Sponsor
  sharing ipd: No