<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/NCT02968043</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-041</org_study_id>
    <nct_id>NCT02968043</nct_id>
  </id_info>
  <brief_title>Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xinhua Hospital Chongming Branch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai First Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Yangzhi Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Yangpu Daqiao Community Health Service Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents.&#xD;
      Exercise is the most common conservative therapy for mild AIS patients. There are increasing&#xD;
      evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the&#xD;
      curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality.&#xD;
      The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle,&#xD;
      fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for&#xD;
      mild AIS patients, and to promote PSSE's application in Shanghai.&#xD;
&#xD;
      Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each&#xD;
      subject will be asked to sign an informed consent form before the subject participate in the&#xD;
      study.&#xD;
&#xD;
      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the&#xD;
      intervention group, in which they will perform PSSEs; or the control group, in which they&#xD;
      will perform generalised physiotherapy exercises. All subjects will be assessed at the&#xD;
      initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic&#xD;
      appearance, radiographic measurement, static balance test, pulmonary function test, bone&#xD;
      quality, and HRQoL will be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal&#xD;
      column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and&#xD;
      physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in&#xD;
      adolescents. Exercise is the most common conservative therapy for mild AIS patients and has&#xD;
      been widely used to reduce spinal deformity and halt curve progression. There are two kinds&#xD;
      of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific&#xD;
      exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There&#xD;
      are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless,&#xD;
      the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to&#xD;
      identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary&#xD;
      function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and&#xD;
      to promote PSSE's application in Shanghai.&#xD;
&#xD;
      The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua&#xD;
      Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi&#xD;
      Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to&#xD;
      inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight,&#xD;
      shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be&#xD;
      evaluated and recorded. The following information will be obtained for all subjects,&#xD;
      including demographic data (for example, age and sex), menarche status for the girls, and&#xD;
      family history. A parent of each subject will be asked to sign an informed consent form&#xD;
      before the subject participate in the study.&#xD;
&#xD;
      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the&#xD;
      intervention group, in which they will perform PSSEs under the guidance of an experienced&#xD;
      physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in&#xD;
      which they will perform generalised physiotherapy exercises. All subjects will receive the&#xD;
      treatment as allocated and will be assessed at the initial visit and 6 months. A&#xD;
      multidimensional, comprehensive evaluation including aesthetic appearance, radiographic&#xD;
      measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be&#xD;
      used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>Change from Baseline Cobb's Angle at 6 months</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Cobb's angle is the &quot;gold standard&quot; measurement on the frontal plane. The standing full spine posterior-anterior X-ray radiograph will be taken at the initial visit and 6 months later.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rotation Angle of Apical Vertebral</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Fall Index at 6 months</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Static balance test will be performed at the initial visit and 6 months later. Fall index will be caculated. Fall index scores from 0 to 100. The higher the fall index the higher the risk of fall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Forced Vital Capacity at 6 months</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Forced Expiratory Volume in First Second at 6 months</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Pulmonary function test will be tested at the initial visit and 6 months later. Forced expiratory volume in first second will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Nondominant Radius Speed of Sound at 6 months</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Bone quality will be measured using a quantitative ultrasound machine (Omnisense 7000P, Sunlight Medical Inc, Israel) at the initial visit and 6 months later. The quantitative ultrasound method can measure speed of sound (SOS) at the distal 1/3 of the radius by axial transmission. The measurement site is defined as the distal 1/3 of the radius. The mean of three measurements of the radius SOS is used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of Scoliosis Research Society-22 Questionnaire</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Scoliosis Research Society-22 questionnaire (SRS-22) scores will be evaluated using the Chinese version of SRS-22 at the initial visit and 6 months later. All subjects will be required to complete SRS-22 independently. SRS-22 is a simple form of questionnaire to assess the HRQoL of AIS patients. It consists of 22 questions in 5 domains including functional activity, pain, self-image, psychological heath and satisfaction to treatment. Each question scores from 1 point (the lowest) to 5 (the highest). Each domain scores from 5 points to 25 points except for satisfaction to the treatment, which scores from 2 points to 10 points. Each domain is expressed as a mean value: the higher the score the better the outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Scoliosis Idiopathic Adolescent</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group will perform generalised physiotherapy exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Generalised physiotherapy exercises consist of stretching and strengthening activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will perform physiotherapeutic scoliosis specific exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists with expertise in scoliosis in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Physiotherapeutic scoliosis specific exercises consist of patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physiotherapeutic scoliosis specific exercises</intervention_name>
    <description>Physiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>generalised physiotherapy exercises</intervention_name>
    <description>Generalised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are consistent with the diagnosis of adolescent idiopathic scoliosis&#xD;
             suggested by Scoliosis Research Society&#xD;
&#xD;
          -  the largest Cobb angle of less than 20 degrees on whole spine posterior-anterior X-ray&#xD;
             radiographs in a standing position&#xD;
&#xD;
          -  10 to 16 years old&#xD;
&#xD;
          -  skeletal immaturity with Risser sign of &lt;3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous exercises or brace treatment history&#xD;
&#xD;
          -  previous operation history of spine or lower extremities&#xD;
&#xD;
          -  scoliosis caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or&#xD;
             other diseases&#xD;
&#xD;
          -  having contraindications to exercises&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qing Du, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qing Du, Ph.D</last_name>
    <phone>25078999</phone>
    <phone_ext>8600</phone_ext>
    <email>duqing810@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xuan Zhou, M.M</last_name>
    <phone>25078999</phone>
    <phone_ext>8609</phone_ext>
    <email>zhouxuanxh@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangyu Chen, MD</last_name>
      <phone>25078999</phone>
      <phone_ext>7485</phone_ext>
      <email>xinhuacru@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Chongming Branch</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>202150</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Li, MD</last_name>
      <phone>18018689957</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 1, 2020</last_update_submitted>
  <last_update_submitted_qc>November 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Qing Du</investigator_full_name>
    <investigator_title>Chief of Rehabilitation Department</investigator_title>
  </responsible_party>
  <keyword>physiotherapeutic scoliosis specific exercise</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/NCT02968043
org study id: XH-16-041
nct id: NCT02968043
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents.
      Exercise is the most common conservative therapy for mild AIS patients. There are increasing
      evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the
      curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality.
      The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle,
      fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for
      mild AIS patients, and to promote PSSE's application in Shanghai.

      Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each
      subject will be asked to sign an informed consent form before the subject participate in the
      study.

      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the
      intervention group, in which they will perform PSSEs; or the control group, in which they
      will perform generalised physiotherapy exercises. All subjects will be assessed at the
      initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic
      appearance, radiographic measurement, static balance test, pulmonary function test, bone
      quality, and HRQoL will be used.
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal
      column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and
      physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in
      adolescents. Exercise is the most common conservative therapy for mild AIS patients and has
      been widely used to reduce spinal deformity and halt curve progression. There are two kinds
      of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific
      exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There
      are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless,
      the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to
      identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary
      function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and
      to promote PSSE's application in Shanghai.

      The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua
      Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi
      Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to
      inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight,
      shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be
      evaluated and recorded. The following information will be obtained for all subjects,
      including demographic data (for example, age and sex), menarche status for the girls, and
      family history. A parent of each subject will be asked to sign an informed consent form
      before the subject participate in the study.

      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the
      intervention group, in which they will perform PSSEs under the guidance of an experienced
      physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in
      which they will perform generalised physiotherapy exercises. All subjects will receive the
      treatment as allocated and will be assessed at the initial visit and 6 months. A
      multidimensional, comprehensive evaluation including aesthetic appearance, radiographic
      measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be
      used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline Cobb's Angle at 6 months
time frame: up to 6 months
description: Cobb's angle is the "gold standard" measurement on the frontal plane. The standing full spine posterior-anterior X-ray radiograph will be taken at the initial visit and 6 months later.
measure: Rotation Angle of Apical Vertebral
time frame: up to 6 months
description: Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.
measure: Change from Baseline Fall Index at 6 months
time frame: up to 6 months
description: Static balance test will be performed at the initial visit and 6 months later. Fall index will be caculated. Fall index scores from 0 to 100. The higher the fall index the higher the risk of fall.
measure: Change from Baseline Forced Vital Capacity at 6 months
time frame: up to 6 months
description: Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.
measure: Change from Baseline Forced Expiratory Volume in First Second at 6 months
time frame: up to 6 months
description: Pulmonary function test will be tested at the initial visit and 6 months later. Forced expiratory volume in first second will be measured.
measure: Change from Baseline Nondominant Radius Speed of Sound at 6 months
time frame: up to 6 months
description: Bone quality will be measured using a quantitative ultrasound machine (Omnisense 7000P, Sunlight Medical Inc, Israel) at the initial visit and 6 months later. The quantitative ultrasound method can measure speed of sound (SOS) at the distal 1/3 of the radius by axial transmission. The measurement site is defined as the distal 1/3 of the radius. The mean of three measurements of the radius SOS is used for analysis.
measure: Scores of Scoliosis Research Society-22 Questionnaire
time frame: up to 6 months
description: Scoliosis Research Society-22 questionnaire (SRS-22) scores will be evaluated using the Chinese version of SRS-22 at the initial visit and 6 months later. All subjects will be required to complete SRS-22 independently. SRS-22 is a simple form of questionnaire to assess the HRQoL of AIS patients. It consists of 22 questions in 5 domains including functional activity, pain, self-image, psychological heath and satisfaction to treatment. Each question scores from 1 point (the lowest) to 5 (the highest). Each domain scores from 5 points to 25 points except for satisfaction to the treatment, which scores from 2 points to 10 points. Each domain is expressed as a mean value: the higher the score the better the outcome.
arm group label: control group
arm group type: Active Comparator
description: Control group will perform generalised physiotherapy exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Generalised physiotherapy exercises consist of stretching and strengthening activities.
arm group label: intervention group
arm group type: Experimental
description: Intervention group will perform physiotherapeutic scoliosis specific exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists with expertise in scoliosis in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Physiotherapeutic scoliosis specific exercises consist of patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living.
intervention type: Other
intervention name: physiotherapeutic scoliosis specific exercises
description: Physiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists.
arm group label: intervention group
intervention type: Other
intervention name: generalised physiotherapy exercises
description: Generalised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists.
arm group label: control group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: No
last name: Qing Du, Ph.D
role: Principal Investigator
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
last name: Qing Du, Ph.D
phone: 25078999
phone ext: 8600
email: duqing810@126.com
last name: Xuan Zhou, M.M
phone: 25078999
phone ext: 8609
email: zhouxuanxh@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Qing Du
investigator title: Chief of Rehabilitation Department
mesh term: Scoliosis
sharing ipd: No