<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/NCT03305185</url>
  </required_header>
  <id_info>
    <org_study_id>UW 16-206</org_study_id>
    <nct_id>NCT03305185</nct_id>
  </id_info>
  <brief_title>Efficacy of Scoliosis Specific Exercise in Patients With Adolescent Idiopathic Scoliosis During Bracing</brief_title>
  <official_title>Efficacy of Scoliosis Specific Exercise (SSE) in Patients With Adolescent Idiopathic Scoliosis (AIS) During Bracing: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific&#xD;
      exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The&#xD;
      goal is to determine if Schroth SSE combined with bracing can is superior in controlling&#xD;
      curve progression when compared with bracing alone. Curve progression is defined as worsening&#xD;
      of coronal Cobb angle of 6 degrees or more.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine,&#xD;
      characterized by a lateral curvature and vertebral rotation. Its prevalence is estimated to&#xD;
      be 2.5% in children between aged 10 and 16 in Hong Kong. Curve progression occurs during&#xD;
      pubertal growth spurt. If the primary curve does not exceed 40 degree at skeletal maturity,&#xD;
      it is unlikely to continue to progress, and there are little or no long-term clinical&#xD;
      consequences. However, if the curve progresses beyond 50 degree during adolescence, it may&#xD;
      cause functional limitation, accelerated disc degeneration with potential neurological&#xD;
      deficit, cosmetic concerns, decreased quality of life, and possible progression in adulthood.&#xD;
      Thus, surgical correction of the deformity with instrumented spinal fusion is usually&#xD;
      recommended if the curve reaches 50 degree during adolescence.&#xD;
&#xD;
      Currently, spinal bracing is the only the only non-operative treatment supported with&#xD;
      high-quality evidence that can prevent curve progression. In a randomized controlled trial,&#xD;
      Weinstein et al. recently reported in the New England Journal of Medicine that bracing was&#xD;
      effective in preventing curve progression to threshold for surgery in 72% of cases. The trial&#xD;
      was terminated early due to the treatment benefit in favor of bracing. Nonetheless, the&#xD;
      authors reported a treatment failure rate of 25% in the randomized cohort, which was similar&#xD;
      to previous published studies. Hence, despite the best available non-operative treatment, the&#xD;
      number of adolescents ultimately requiring surgery remains substantial. Surgery is associated&#xD;
      with medical comorbidities, can cause psychosocial stress to the children and their families,&#xD;
      and has significant financial impact on healthcare, with the total costs of spinal surgery to&#xD;
      correct AIS ranked second only to appendicitis among children 10 to 17 years of age.&#xD;
      Consequently, further effective strategies to prevent scoliosis progression in children are&#xD;
      needed.&#xD;
&#xD;
      Scoliosis-specific exercise (SSE) has been proposed as an additional non-operative&#xD;
      intervention that may reduce curve progression during the adolescent growth spurt. However,&#xD;
      the standard of care for non-operative treatment of AIS varies widely between North America&#xD;
      and Europe, and the use of SSE is not universally accepted. SSE is a potentially low-cost&#xD;
      intervention that will be of substantial benefit even if a relative risk reduction in curve&#xD;
      progression or reaching the threshold for surgery is reduced in a modest proportion of those&#xD;
      participating.&#xD;
&#xD;
      SSE, as opposed to generalized physiotherapy, consists of individually-adapted exercises that&#xD;
      aim to promote spinal realignment through self-correction and stabilization, as well as&#xD;
      modulating patterns of trunk muscles recruitment. Electromyography (EMG) of paraspinal and&#xD;
      abdominal muscles in AIS patients revealed disrupted patterns of muscles recruitment, which&#xD;
      are associated with a disparity in trunk isometric rotation strength between sides. AIS&#xD;
      patients demonstrate proprioceptive and balance control problems, along with a distorted body&#xD;
      schema, resulting in a mismatch between the actual spinal alignment and the patients'&#xD;
      internal representation of the body. SSE aims to reverse the anomalous patterns of muscle&#xD;
      recruitment through training, and modify the body schema with visual and somatosensory&#xD;
      feedback. This forms the theoretical neurophysiological basis for using this treatment&#xD;
      strategy for AIS.&#xD;
&#xD;
      Schroth SSE is one of the most studied and widely-used schools of SSE. It is a technique&#xD;
      tailored to the type of scoliosis and the curve magnitude of each patient. It is based on&#xD;
      vertebrae deflections and sagittal corrections that result in horizontal vertebrae&#xD;
      de-rotation. It uses rotational breathing and postural auto-correction to reverse the&#xD;
      underlying impairments in spinal muscle function, postural control and proprioception which&#xD;
      contribute to the development of curvature in AIS. Patients will also be given cognitive&#xD;
      behavioral strategies to empower them to self-manage their conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 18, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <intervention_model_description>Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian.&#xD;
Recruited patients will be randomly assigned to either SSE group or control group in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, post-treatment 3 months, 6 months, 12 months and until skeletal maturity.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Assessor, statistician and investigator blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>1. To evaluate the effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare changes in sagittal plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To evaluate the effect of Schroth SSE during bracing compared with bracing alone on sagittal plane radiological parameter using EOS Imaging System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare changes in transverse plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To evaluate the effect of Schroth SSE during bracing compared with bracing alone on transverse plane radiological parameter using EOS Imaging System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare changes in surface topography between Schroth SSE with bracing and bracing alone using Bunnell's scoliometer</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using Bunnell's scoliometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare changes in surface topography between Schroth SSE with bracing and bracing alone using clinical photography</measure>
    <time_frame>baseline, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using clinical photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare changes in surface topography between Schroth SSE with bracing and bracing alone using VITUS Smart XXL 3D body scanner system</measure>
    <time_frame>baseline, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using VITUS Smart XXL 3D body scanner system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months, until skeletal maturity</time_frame>
    <description>To measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Schroth SSE with Bracing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bracing alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Schroth SSE with Bracing</intervention_name>
    <description>Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.</description>
    <arm_group_label>Schroth SSE with Bracing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bracing alone</intervention_name>
    <description>Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.</description>
    <arm_group_label>Bracing alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AIS&#xD;
&#xD;
          -  Male or female from 10 to 15 year-old, inclusive, at the time of consent provided&#xD;
&#xD;
          -  Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual&#xD;
             fusion of the iliac apophysis) of 0, 1, or 2&#xD;
&#xD;
          -  Cobb angle of 25-40&#xD;
&#xD;
          -  No prior conservative or surgical treatment for AIS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An underlying cause or association that may cause scoliosis&#xD;
&#xD;
          -  Leg length discrepancies or lower limb deformities that may interfere with spinal&#xD;
             posture&#xD;
&#xD;
          -  Previous spinal surgery&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Those receiving any other forms of treatment including alternative medicine for the&#xD;
             treatment of their scoliosis&#xD;
&#xD;
          -  Those who are unable to return for follow-up to complete the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Kenny Kwan, BMBCh(Oxon)</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duchess of Kent Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Kenny Kwan</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>AIS</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>


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/NCT03305185
org study id: UW 16-206
nct id: NCT03305185
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific
      exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The
      goal is to determine if Schroth SSE combined with bracing can is superior in controlling
      curve progression when compared with bracing alone. Curve progression is defined as worsening
      of coronal Cobb angle of 6 degrees or more.
Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine,
      characterized by a lateral curvature and vertebral rotation. Its prevalence is estimated to
      be 2.5% in children between aged 10 and 16 in Hong Kong. Curve progression occurs during
      pubertal growth spurt. If the primary curve does not exceed 40 degree at skeletal maturity,
      it is unlikely to continue to progress, and there are little or no long-term clinical
      consequences. However, if the curve progresses beyond 50 degree during adolescence, it may
      cause functional limitation, accelerated disc degeneration with potential neurological
      deficit, cosmetic concerns, decreased quality of life, and possible progression in adulthood.
      Thus, surgical correction of the deformity with instrumented spinal fusion is usually
      recommended if the curve reaches 50 degree during adolescence.

      Currently, spinal bracing is the only the only non-operative treatment supported with
      high-quality evidence that can prevent curve progression. In a randomized controlled trial,
      Weinstein et al. recently reported in the New England Journal of Medicine that bracing was
      effective in preventing curve progression to threshold for surgery in 72% of cases. The trial
      was terminated early due to the treatment benefit in favor of bracing. Nonetheless, the
      authors reported a treatment failure rate of 25% in the randomized cohort, which was similar
      to previous published studies. Hence, despite the best available non-operative treatment, the
      number of adolescents ultimately requiring surgery remains substantial. Surgery is associated
      with medical comorbidities, can cause psychosocial stress to the children and their families,
      and has significant financial impact on healthcare, with the total costs of spinal surgery to
      correct AIS ranked second only to appendicitis among children 10 to 17 years of age.
      Consequently, further effective strategies to prevent scoliosis progression in children are
      needed.

      Scoliosis-specific exercise (SSE) has been proposed as an additional non-operative
      intervention that may reduce curve progression during the adolescent growth spurt. However,
      the standard of care for non-operative treatment of AIS varies widely between North America
      and Europe, and the use of SSE is not universally accepted. SSE is a potentially low-cost
      intervention that will be of substantial benefit even if a relative risk reduction in curve
      progression or reaching the threshold for surgery is reduced in a modest proportion of those
      participating.

      SSE, as opposed to generalized physiotherapy, consists of individually-adapted exercises that
      aim to promote spinal realignment through self-correction and stabilization, as well as
      modulating patterns of trunk muscles recruitment. Electromyography (EMG) of paraspinal and
      abdominal muscles in AIS patients revealed disrupted patterns of muscles recruitment, which
      are associated with a disparity in trunk isometric rotation strength between sides. AIS
      patients demonstrate proprioceptive and balance control problems, along with a distorted body
      schema, resulting in a mismatch between the actual spinal alignment and the patients'
      internal representation of the body. SSE aims to reverse the anomalous patterns of muscle
      recruitment through training, and modify the body schema with visual and somatosensory
      feedback. This forms the theoretical neurophysiological basis for using this treatment
      strategy for AIS.

      Schroth SSE is one of the most studied and widely-used schools of SSE. It is a technique
      tailored to the type of scoliosis and the curve magnitude of each patient. It is based on
      vertebrae deflections and sagittal corrections that result in horizontal vertebrae
      de-rotation. It uses rotational breathing and postural auto-correction to reverse the
      underlying impairments in spinal muscle function, postural control and proprioception which
      contribute to the development of curvature in AIS. Patients will also be given cognitive
      behavioral strategies to empower them to self-manage their conditions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian.
Recruited patients will be randomly assigned to either SSE group or control group in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, post-treatment 3 months, 6 months, 12 months and until skeletal maturity.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Assessor, statistician and investigator blinded
measure: Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: 1. To evaluate the effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
measure: Compare changes in sagittal plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To evaluate the effect of Schroth SSE during bracing compared with bracing alone on sagittal plane radiological parameter using EOS Imaging System
measure: Compare changes in transverse plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To evaluate the effect of Schroth SSE during bracing compared with bracing alone on transverse plane radiological parameter using EOS Imaging System
measure: Compare changes in surface topography between Schroth SSE with bracing and bracing alone using Bunnell's scoliometer
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using Bunnell's scoliometer
measure: Compare changes in surface topography between Schroth SSE with bracing and bracing alone using clinical photography
time frame: baseline, 6 months, 12 months, until skeletal maturity
description: To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using clinical photography
measure: Compare changes in surface topography between Schroth SSE with bracing and bracing alone using VITUS Smart XXL 3D body scanner system
time frame: baseline, 6 months, 12 months, until skeletal maturity
description: To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using VITUS Smart XXL 3D body scanner system
measure: Measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire
measure: Measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L
measure: Measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)
measure: Measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings
time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
description: To measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings
arm group label: Schroth SSE with Bracing
arm group type: Experimental
description: Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.
arm group label: Bracing alone
arm group type: Active Comparator
description: Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.
intervention type: Combination Product
intervention name: Schroth SSE with Bracing
description: Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.
arm group label: Schroth SSE with Bracing
intervention type: Device
intervention name: Bracing alone
description: Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.
arm group label: Bracing alone
criteria: 
gender: All
minimum age: 10 Years
maximum age: 15 Years
healthy volunteers: No
last name: Dr Kenny Kwan, BMBCh(Oxon)
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Kenny Kwan
investigator title: Clinical Assistant Professor
mesh term: Scoliosis
sharing ipd: No