<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/NCT03779581</url>
  </required_header>
  <id_info>
    <org_study_id>MajmaahUniversity</org_study_id>
    <nct_id>NCT03779581</nct_id>
  </id_info>
  <brief_title>Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial</brief_title>
  <official_title>Self Correction Exercises for Idiopathic Scoliosis Among Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Majmaah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Majmaah 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>
      Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown&#xD;
      cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph&#xD;
      with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the&#xD;
      severity of the spinal deformity, conservative treatments and surgery are used to treat AIS.&#xD;
      Patients whose spinal curvature is greater than 45 degrees are typically considered for&#xD;
      surgery. The majority of patients with AIS receive conservative treatments to prevent and&#xD;
      slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific&#xD;
      exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic&#xD;
      and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self&#xD;
      correction exercises are the group of spinal extension, lateral spinal flexion and rotational&#xD;
      exercises performed to correct spinal deviation. Exercises are performed in a different&#xD;
      fundamental postures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scoliosis is a malformation of the musculoskeletal system that is defined by lateral&#xD;
      deviation of the spine, which is typically accompanied by vertebral rotation and lordosis.&#xD;
      The term &quot;scoliosis&quot; refers to the curvature of the spine that results from the condition&#xD;
      (3-dimensional deformity). Scoliosis in female teenagers often reaches its most advanced&#xD;
      stage between the ages of 11 and 16 years old. In general, scoliosis may be broken down into&#xD;
      two categories: structural and non-structural scoliosis. The level of severity and the degree&#xD;
      of deformity of the spine are the major characteristics that differentiate the two groups. It&#xD;
      is common practice to refer to the structural type of scoliosis as a sort of spinal deformity&#xD;
      that cannot be corrected without surgical intervention. Bracing, exercises, and education are&#xD;
      some of the conservative treatments that may be used to control non-structural spinal&#xD;
      deformity, which is a movable disorder. Scoliosis that is not treated properly may advance to&#xD;
      a functionally degraded condition, which is characterized by physical asymmetry, muscular&#xD;
      imbalance, back discomfort, and considerable respiratory disruption. This can lead to&#xD;
      distorted body image and a loss of self-esteem in the patient. Idiopathic adolescent&#xD;
      scoliosis, more commonly known as AIS, is the diagnosis that is typically made in children&#xD;
      who are otherwise healthy but have a spinal curvature of at least ten degrees but less than&#xD;
      fifty degrees. This curvature range is what determines whether a child is considered to have&#xD;
      AIS. While treating scoliosis, the primary goal of therapy should be to slow or stop the&#xD;
      disease's development so that the treatment may be regarded effective. Non-conservative&#xD;
      therapies often entail surgical techniques for the correction of spinal abnormalities;&#xD;
      nevertheless, these operations do not come without associated risks. Individuals who arrive&#xD;
      with a scoliosis curvature of less than 40 degrees have the potential to be candidates for&#xD;
      conservative treatments such as physiotherapy scoliosis-specific exercise (PSSE), with or&#xD;
      without the concomitant use of an external brace.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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>
    <intervention_model_description>1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The researcher, surgeons, and physiotherapist did not participate in randomization, treatment, or outcome assessments. The assessor was blinded. A computer-generated sequence inside pre-sealed opaque envelopes with sequentially numbered opaque envelopes randomly allocated individuals to the groups. To ensure a fair distribution of curve types between the two groups (54 per group), a random size (4-8) blocked randomization was stratified for the six curve types. Participants were asked not to reveal their group affiliations to ensure evaluators were blind. The statistician was also insulated from group allocation coding. During routine clinic visits, a trained technician blinded to study participation took radiographs. An expert blinded to groups and time measured the radiographs.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cobb angle</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Angulation calculated on X-ray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SRS 22</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Scoliosis rating scale 22 items</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Scoliosis Idiopathic</condition>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self Correction exercises</intervention_name>
    <description>Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>orthotic devices</intervention_name>
    <description>the orthotic devices designed to correct the scoliosis curve</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        10-16-year-olds with AIS, all sexes, all curve kinds, curves between 10° and 45°, Risser&#xD;
        grade 0 to 5, with or without brace, and the capacity to attend weekly checkups.&#xD;
&#xD;
        Exclusion criteria included patients with a diagnosis other than AIS, those who had&#xD;
        finished brace therapy, those planned for surgery, those with a follow-up scheduled beyond&#xD;
        62 months, and those who had had prior spine surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faizan Kashoo</name>
      <address>
        <city>Riyadh</city>
        <zip>11952</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Majmaah University</investigator_affiliation>
    <investigator_full_name>faizan kashoo, PT</investigator_full_name>
    <investigator_title>Lecturer, Department of physical Therapy and Health Rehabilitation</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <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/NCT03779581
org study id: MajmaahUniversity
nct id: NCT03779581
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown
      cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph
      with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the
      severity of the spinal deformity, conservative treatments and surgery are used to treat AIS.
      Patients whose spinal curvature is greater than 45 degrees are typically considered for
      surgery. The majority of patients with AIS receive conservative treatments to prevent and
      slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific
      exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic
      and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self
      correction exercises are the group of spinal extension, lateral spinal flexion and rotational
      exercises performed to correct spinal deviation. Exercises are performed in a different
      fundamental postures.
Scoliosis is a malformation of the musculoskeletal system that is defined by lateral
      deviation of the spine, which is typically accompanied by vertebral rotation and lordosis.
      The term "scoliosis" refers to the curvature of the spine that results from the condition
      (3-dimensional deformity). Scoliosis in female teenagers often reaches its most advanced
      stage between the ages of 11 and 16 years old. In general, scoliosis may be broken down into
      two categories: structural and non-structural scoliosis. The level of severity and the degree
      of deformity of the spine are the major characteristics that differentiate the two groups. It
      is common practice to refer to the structural type of scoliosis as a sort of spinal deformity
      that cannot be corrected without surgical intervention. Bracing, exercises, and education are
      some of the conservative treatments that may be used to control non-structural spinal
      deformity, which is a movable disorder. Scoliosis that is not treated properly may advance to
      a functionally degraded condition, which is characterized by physical asymmetry, muscular
      imbalance, back discomfort, and considerable respiratory disruption. This can lead to
      distorted body image and a loss of self-esteem in the patient. Idiopathic adolescent
      scoliosis, more commonly known as AIS, is the diagnosis that is typically made in children
      who are otherwise healthy but have a spinal curvature of at least ten degrees but less than
      fifty degrees. This curvature range is what determines whether a child is considered to have
      AIS. While treating scoliosis, the primary goal of therapy should be to slow or stop the
      disease's development so that the treatment may be regarded effective. Non-conservative
      therapies often entail surgical techniques for the correction of spinal abnormalities;
      nevertheless, these operations do not come without associated risks. Individuals who arrive
      with a scoliosis curvature of less than 40 degrees have the potential to be candidates for
      conservative treatments such as physiotherapy scoliosis-specific exercise (PSSE), with or
      without the concomitant use of an external brace.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The researcher, surgeons, and physiotherapist did not participate in randomization, treatment, or outcome assessments. The assessor was blinded. A computer-generated sequence inside pre-sealed opaque envelopes with sequentially numbered opaque envelopes randomly allocated individuals to the groups. To ensure a fair distribution of curve types between the two groups (54 per group), a random size (4-8) blocked randomization was stratified for the six curve types. Participants were asked not to reveal their group affiliations to ensure evaluators were blind. The statistician was also insulated from group allocation coding. During routine clinic visits, a trained technician blinded to study participation took radiographs. An expert blinded to groups and time measured the radiographs.
measure: Cobb angle
time frame: 1-2 hours
description: Angulation calculated on X-ray
measure: SRS 22
time frame: 1-2 hours
description: Scoliosis rating scale 22 items
arm group label: Exercise Group
arm group type: Experimental
description: The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.
arm group label: Control Group
arm group type: Active Comparator
description: All patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010).
intervention type: Other
intervention name: Self Correction exercises
description: Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.
arm group label: Exercise Group
intervention type: Device
intervention name: orthotic devices
description: the orthotic devices designed to correct the scoliosis curve
arm group label: Control Group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Majmaah University
investigator full name: faizan kashoo, PT
investigator title: Lecturer, Department of physical Therapy and Health Rehabilitation
mesh term: Scoliosis
sharing ipd: Undecided