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/NCT05985902</url>
    </required_header>
    <id_info>
      <org_study_id>BVUsyildirim03</org_study_id>
      <nct_id>NCT05985902</nct_id>
    </id_info>
    <brief_title>The Efficiency of Different Exercise Methods in Adolescent Idiopathic Scoliosis</brief_title>
    <official_title>The Efficiency of Different Exercise Methods in Adolescent Idiopathic Scoliosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bezmialem Vakif University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bezmialem Vakif 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 vertebral column is a structure that transfers the weight of the head and torso to the&#xD;
        lower extremity, provides trunk movements and protects the spinal cord.A three dimensional&#xD;
        deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above,&#xD;
        including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal&#xD;
        plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic&#xD;
        scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the&#xD;
        closure of growth plates.&#xD;
  &#xD;
        Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of&#xD;
        impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ&#xD;
        disorders and pain. In addition, the quality of life in these individuals is also seen to&#xD;
        decrease.&#xD;
  &#xD;
        There are no studies in the literature examining the effects of Schroth exercise training on&#xD;
        trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and&#xD;
        quality of life in children with adolescent idiopathic scoliosis.&#xD;
  &#xD;
        The aim of our study is to examine whether Schroth exercise training has an effect on trunk&#xD;
        muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of&#xD;
        life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis.&#xD;
        It is thought that this study will fill the gap in the literature with the original&#xD;
        information it will bring to the literature and will shed light on future studies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>Isokinetic Muscle Strength</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>In order to examine the muscle strength of the patients and the effectiveness of the treatment, the muscle strength of the individuals will be evaluated with the Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) isokinetic dynamometer device. The Biodex isokinetic dynamometer device adapts at a constant speed, allowing a dynamic test that can give resistance. The adaptiveness of the resistance and the ability to give the same resistance throughout the entire range of motion provide maximum muscle strength. In addition to this situation, the performance of the muscles can be evaluated at different angular velocities. Muscle function and muscle strength can be determined during maximum muscle contraction by using a linear scale with isokinetic dynamometer, which is an objective assessment, and with this method, information about the strength of the upper and lower extremities and trunk muscles can be obtained.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle Stiffness</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Shear Wave Elastography, also known as dynamic elastography, is a sonoelastography examination that has been developed and rapidly developed in recent years, and it provides additional information about tissue properties by evaluating tissue flexibility that can contribute to the diagnosis. In this technique application, a short-term, high-power acoustic repulsive radiation force is applied to the tissue with ultrasound probes. This force causes small displacements in tissues. These displacements in the horizontal plane are called &quot;shear waves&quot; and the rate of progression of these waves in the tissue can be measured. The shear wave velocity is directly proportional to the hardness of the tissue. The velocity values obtained show the objective elasticity values. Patients' spinal and abdominal muscle stiffness will be evaluated with the Toshiba Aplio 500 (Toshiba Medical Systems Corporation, Japan).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory Muscle Strength</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK). Pressures will be assessed by measurements of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during a few seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) by mouth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postural Stability</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Postural Stability and balance will be evaluated with the Biodex Balance System®. The Biodex Balance System® is a validated and reliable instrument used to assess postural stability, limits of stability and fall risk. It consists of balance platform, arm supports, screen and printer. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degrees in each direction) according to the test to be applied.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cobb Angle</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>The Cobb angle records at the first visit of the patients. The Cobb angle is the angle between the lines drawn perpendicular to the endplates first and last vertebrae involved in the curvature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Angle of Trunk Rotation</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Measurement will be applied with Bunnell Scoliometer by physiotherapist.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life (Scoliosis Research Society-22)</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Measurement will be applied with Scoliosis Research Society-22 Questionnaire. The scale consists of 22 questions and 5 subgroups of questions. Subgroups; pain, evaluation of general appearance, spinal functions, mental health and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated by summing up under the total score. Scores are calculated by assigning an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer; 1 and the most positive gets 5 points. High scores on the scale indicate an increase in quality of life, and low scores indicate a decrease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cosmetic Deformity Perception</measure>
      <time_frame>Baseline and after 12 weeks</time_frame>
      <description>Measurement will be applied with The Walter Reed Visual Assessment Scale. In the scale, deformity is categorized with 7 different aspects. Each of the 7 items contains a set of 5 figures representing the severity of the deformity. In these sets, there are visuals evaluating spine deformity, rib protrusion, waist protrusion, chest deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The visuals include posterior views of the deformity and assess the patient's sense of how other people see their back. The selected images are scored as the lowest &quot;1&quot; and the highest &quot;5&quot;, and the higher the total score obtained, the more negative-worse the perceived deformity is defined.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Adolescent Idiopathic Scoliosis</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Core stabilization exercise training will be given to the control group for 12 weeks, 7 days a week, for 60 minutes. Core stabilization exercises will be applied to this group under the supervision of a physiotherapist for 2 days in our unit, while home-based core stabilization exercise training will be given on other days of the week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Training Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the first evaluation, the training group will be given Schroth exercise training for 12 weeks, 7 days a week, for 60 minutes. This group will be given Schroth exercises under the supervision of a physiotherapist for 2 days in our unit, while home-based Schroth exercise training will be given on other days of the week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Core Stabilization Exercises</intervention_name>
      <description>Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the &quot;local system&quot; muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the &quot;global system&quot; includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus ma</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Schroth Exercises</intervention_name>
      <description>In the Schroth exercise training, there are 3-dimensional exercises that include the principles of axial reach, deflection, derotation, rotational breathing and stabilization.</description>
      <arm_group_label>Training Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with AIS scoliosis&#xD;
  &#xD;
            -  Individuals agreeing to participate in the study&#xD;
  &#xD;
            -  Patients between the ages of 10-20&#xD;
  &#xD;
            -  Patients with AIS whose Cobb angle measured on X-ray is between 15-40 degrees&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental&#xD;
               disorders which may affect the assessments results.&#xD;
  &#xD;
            -  Patients previously undertaken any of spinal surgeries.&#xD;
  &#xD;
            -  Patients involved in exercise training 3 or more days a week&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sefa Yıldırım, PT, MSc</last_name>
      <phone>+905385984870</phone>
      <email>sefa.yyldrm@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bezmialem Vakıf University</name>
        <address>
          <city>Istanbul</city>
          <state>Eyüp</state>
          <zip>34050</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sefa Yıldırım, PT, MSc</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adolescent Idiopathic scoliosis</keyword>
    <keyword>Schroth Exercises</keyword>
    <keyword>Scoliosis Specific Exercises</keyword>
    <keyword>Trunk Muscle Strength</keyword>
    <keyword>Respiratory Muscle Strength</keyword>
    <keyword>Muscle Stiffness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</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/NCT05985902
  org study id: BVUsyildirim03
  nct id: NCT05985902
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The vertebral column is a structure that transfers the weight of the head and torso to the
        lower extremity, provides trunk movements and protects the spinal cord.A three dimensional
        deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above,
        including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal
        plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic
        scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the
        closure of growth plates.
  
        Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of
        impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ
        disorders and pain. In addition, the quality of life in these individuals is also seen to
        decrease.
  
        There are no studies in the literature examining the effects of Schroth exercise training on
        trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and
        quality of life in children with adolescent idiopathic scoliosis.
  
        The aim of our study is to examine whether Schroth exercise training has an effect on trunk
        muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of
        life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis.
        It is thought that this study will fill the gap in the literature with the original
        information it will bring to the literature and will shed light on future studies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Isokinetic Muscle Strength
  time frame: Baseline and after 12 weeks
  description: In order to examine the muscle strength of the patients and the effectiveness of the treatment, the muscle strength of the individuals will be evaluated with the Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) isokinetic dynamometer device. The Biodex isokinetic dynamometer device adapts at a constant speed, allowing a dynamic test that can give resistance. The adaptiveness of the resistance and the ability to give the same resistance throughout the entire range of motion provide maximum muscle strength. In addition to this situation, the performance of the muscles can be evaluated at different angular velocities. Muscle function and muscle strength can be determined during maximum muscle contraction by using a linear scale with isokinetic dynamometer, which is an objective assessment, and with this method, information about the strength of the upper and lower extremities and trunk muscles can be obtained.
  measure: Muscle Stiffness
  time frame: Baseline and after 12 weeks
  description: Shear Wave Elastography, also known as dynamic elastography, is a sonoelastography examination that has been developed and rapidly developed in recent years, and it provides additional information about tissue properties by evaluating tissue flexibility that can contribute to the diagnosis. In this technique application, a short-term, high-power acoustic repulsive radiation force is applied to the tissue with ultrasound probes. This force causes small displacements in tissues. These displacements in the horizontal plane are called "shear waves" and the rate of progression of these waves in the tissue can be measured. The shear wave velocity is directly proportional to the hardness of the tissue. The velocity values obtained show the objective elasticity values. Patients' spinal and abdominal muscle stiffness will be evaluated with the Toshiba Aplio 500 (Toshiba Medical Systems Corporation, Japan).
  measure: Respiratory Muscle Strength
  time frame: Baseline and after 12 weeks
  description: Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK). Pressures will be assessed by measurements of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during a few seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) by mouth.
  measure: Postural Stability
  time frame: Baseline and after 12 weeks
  description: Postural Stability and balance will be evaluated with the Biodex Balance System®. The Biodex Balance System® is a validated and reliable instrument used to assess postural stability, limits of stability and fall risk. It consists of balance platform, arm supports, screen and printer. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degrees in each direction) according to the test to be applied.
  measure: Cobb Angle
  time frame: Baseline and after 12 weeks
  description: The Cobb angle records at the first visit of the patients. The Cobb angle is the angle between the lines drawn perpendicular to the endplates first and last vertebrae involved in the curvature.
  measure: Angle of Trunk Rotation
  time frame: Baseline and after 12 weeks
  description: Measurement will be applied with Bunnell Scoliometer by physiotherapist.
  measure: Quality of Life (Scoliosis Research Society-22)
  time frame: Baseline and after 12 weeks
  description: Measurement will be applied with Scoliosis Research Society-22 Questionnaire. The scale consists of 22 questions and 5 subgroups of questions. Subgroups; pain, evaluation of general appearance, spinal functions, mental health and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated by summing up under the total score. Scores are calculated by assigning an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer; 1 and the most positive gets 5 points. High scores on the scale indicate an increase in quality of life, and low scores indicate a decrease.
  measure: Cosmetic Deformity Perception
  time frame: Baseline and after 12 weeks
  description: Measurement will be applied with The Walter Reed Visual Assessment Scale. In the scale, deformity is categorized with 7 different aspects. Each of the 7 items contains a set of 5 figures representing the severity of the deformity. In these sets, there are visuals evaluating spine deformity, rib protrusion, waist protrusion, chest deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The visuals include posterior views of the deformity and assess the patient's sense of how other people see their back. The selected images are scored as the lowest "1" and the highest "5", and the higher the total score obtained, the more negative-worse the perceived deformity is defined.
  arm group label: Control Group
  arm group type: Active Comparator
  description: Core stabilization exercise training will be given to the control group for 12 weeks, 7 days a week, for 60 minutes. Core stabilization exercises will be applied to this group under the supervision of a physiotherapist for 2 days in our unit, while home-based core stabilization exercise training will be given on other days of the week.
  arm group label: Training Group
  arm group type: Experimental
  description: After the first evaluation, the training group will be given Schroth exercise training for 12 weeks, 7 days a week, for 60 minutes. This group will be given Schroth exercises under the supervision of a physiotherapist for 2 days in our unit, while home-based Schroth exercise training will be given on other days of the week.
  intervention type: Other
  intervention name: Core Stabilization Exercises
  description: Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus ma
  arm group label: Control Group
  intervention type: Other
  intervention name: Schroth Exercises
  description: In the Schroth exercise training, there are 3-dimensional exercises that include the principles of axial reach, deflection, derotation, rotational breathing and stabilization.
  arm group label: Training Group
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 20 Years
  healthy volunteers: No
  last name: Sefa Yıldırım, PT, MSc
  phone: +905385984870
  email: sefa.yyldrm@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Scoliosis
  sharing ipd: No