<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/NCT03825159</url>
  </required_header>
  <id_info>
    <org_study_id>CCH-170102</org_study_id>
    <nct_id>NCT03825159</nct_id>
  </id_info>
  <brief_title>A New Spinal Orthosis for Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>A New Spinal Orthosis With an Integrated System of Electric Surface Stimulation and Heat Sensing for Adolescent Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</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 new device with digital technology provides a new avenue to enable clinicians to&#xD;
      communicate wirelessly with the imbedded core system such that they can adjust the electrical&#xD;
      stimulation parameters and retrieve the temperature data for further compliance analysis. The&#xD;
      smart phone and cloud technology can be effectively applied for both security and&#xD;
      convenience. The electrical stimulation technology integrated with the total contact spinal&#xD;
      orthosis combines the external correction forces on the spinal skeleton from the passive&#xD;
      orthosis with the muscle forces at the lateral trunk from the stimulation process. The&#xD;
      electrical stimulation is purposely to tone the muscle in order to replace the external&#xD;
      mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may&#xD;
      maintain the correction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal orthosis is an option to treat Adolescent Idiopathic Scoliosis (AIS) and is the most&#xD;
      commonly used among conservative treatment. According to Scoliosis Research Society (SRS),&#xD;
      orthotic treatment is indicated for AIS patients with curves greater than 25˚ but smaller&#xD;
      than 45˚. However, the in-brace correction is hardly maintained and the effectiveness of&#xD;
      orthotic treatment is limited, which has been an impetus to develop a more effective method&#xD;
      for AIS patients to fulfill the unmet need. In order the orthosis is effective, biomechanical&#xD;
      intervention and the patient compliance are two key factors. The purpose of this two-year&#xD;
      project is to develop a new spinal orthosis in which an integrated system of electric surface&#xD;
      stimulation and heat sensing is imbedded such that the AIS will be effectively treated with&#xD;
      the mechanical orthosis plus a nocturnal use of electrical stimulation. In addition to the&#xD;
      already stellar device, a totally new concept of spine erectability is proposed to provide&#xD;
      evidence that can manifest the unique value of orthotic treatment as opposed to surgery. It&#xD;
      is hypothesized that the new spinal orthosis would not only reduce the Cobb angle and apical&#xD;
      rotation but also would strengthen the spine erectability in AIS patients. The new device&#xD;
      with digital technology provides a new avenue to enable clinicians to communicate wirelessly&#xD;
      with the imbedded core system such that they can adjust the electrical stimulation parameters&#xD;
      and retrieve the temperature data for further compliance analysis. The smart phone and cloud&#xD;
      technology can be effectively applied for both security and convenience. The electrical&#xD;
      stimulation technology integrated with the total contact spinal orthosis combines the&#xD;
      external correction forces on the spinal skeleton from the passive orthosis with the muscle&#xD;
      forces at the lateral trunk from the stimulation process. The electrical stimulation is&#xD;
      purposely to tone the muscle in order to replace the external mechanical forces gradually.&#xD;
      Ultimately, when being weaned off the orthosis, patients may maintain the correction. With&#xD;
      the spinal orthosis, the applied current in stimulation process would be reduced and the skin&#xD;
      irritation would too. First year, there will be three tasks. An instrument will be developed&#xD;
      for clinicians to assess the applicability of electrical surface stimulation to each AIS&#xD;
      patient. System integration of the spinal orthosis with electrical surface stimulation and&#xD;
      heat sensing will be accomplished. Clinical study of the effectiveness of passive spinal&#xD;
      orthoses on 30 AIS subjects as a control group, where the Cobb angle, apical rotation and&#xD;
      spine erectability will be measured before treatment and after. Second year, another 30 AIS&#xD;
      patients will be recruited; the applicability of electrical surface stimulation will be&#xD;
      assessed; and the new spinal orthosis will be applied to the experiment group. The Cobb&#xD;
      angle, apical rotation and spine erectability will be measured before treatment and after for&#xD;
      each subject. Independent t test will be carried out for the two groups to test the&#xD;
      hypothesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Cobb angle</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>When measuring Cobb angle, the investigators should identify the upper and lower end vertebra. Then, the investigators draw perpendicular lines extending along the vertebral borders. The angle where two perpendicular lines meet is called Cobb angle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Spine erectability</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>Spine erectability is to define the physiological ability of the spine to maintain it erect against gravity and will be assessed without wearing orthoses.&#xD;
The force F acting at the apex is the weights of the head and two upper limbs plus 7/17 trunk weight, which can be calculated with the readily available anthropometric data. The bending moment M at T8 equals the applied force F multiplies the lever arm d, which is the distance between the force and the weight line.&#xD;
SE=(Weight*7/17)*d/(Cobb angle in standing-Cobb angle in supine)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Apical rotation</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>Apical rotation is the degree of apical vertebral rotation .The Raimondi method uses the projection of the vertebral pedicles and the width of the vertebra as a reference for the measuring. The largest axis of the pedicle is demarcated and measured on the side of the curve convexity, and the distance of the longitudinal line from the pedicle to the border of the vertebra on the convex side is measured. Those two values are transported to the ruler, and the value of the rotation is obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Back muscles surface ElectroMyoGraphy (EMG)</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>Use a non-invasive surface EMG tool to collect muscle activities on the upper and lower back area, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back movement pathway</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>Use cameras to record the back motion pathway during trunk flexion-extension &amp; lateral rotations, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distributions of Pressure under the feet</measure>
    <time_frame>base line, 6th month and 12th month</time_frame>
    <description>Use a flat pressure mat embedded in the walkway to collect the foot pressure distribution during static standing and dynamic walking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The nerve morphological connectivity</measure>
    <time_frame>base line,12th month</time_frame>
    <description>The subject's diffusion tensor features are extracted from functional Magnetic Resonance Imaging of head. The features would include the never connectivity, pathway, the size of nuclei.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Scoliosis; Adolescence</condition>
  <arm_group>
    <arm_group_label>ES group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using spinal orthosis with an integrated system of electric surface stimulation and heat sensing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>brace group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using spinal orthosis BRACE</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing</intervention_name>
    <description>The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process.</description>
    <arm_group_label>ES group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>spinal orthosis</intervention_name>
    <description>The ventrally opened total contact spinal orthosis will be designed and made of Copolymer and Aliplast. Correcting pressure points have to use the pressure pads at relevant points.</description>
    <arm_group_label>brace group</arm_group_label>
    <other_name>Scoliosis brace</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) the range of age should be from ten years old to seventeen years old and (2) the&#xD;
             Cobb angle should be from 20°to 45°.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1)not primary idiopathic scoliosis (2)Unable to wear the all-day brace&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TASEN WEI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PENGTA LIU</last_name>
    <phone>88647238595</phone>
    <phone_ext>7427</phone_ext>
    <email>105546@cch.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhua Christian Hospital Taiwan</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tseng</last_name>
      <phone>886-4-7238595</phone>
      <phone_ext>4077</phone_ext>
      <email>tasen@cch.org.tw</email>
    </contact>
    <investigator>
      <last_name>Tasen Wei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>Ta-Sen Wei,MD</investigator_full_name>
    <investigator_title>physian</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03825159
org study id: CCH-170102
nct id: NCT03825159
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The new device with digital technology provides a new avenue to enable clinicians to
      communicate wirelessly with the imbedded core system such that they can adjust the electrical
      stimulation parameters and retrieve the temperature data for further compliance analysis. The
      smart phone and cloud technology can be effectively applied for both security and
      convenience. The electrical stimulation technology integrated with the total contact spinal
      orthosis combines the external correction forces on the spinal skeleton from the passive
      orthosis with the muscle forces at the lateral trunk from the stimulation process. The
      electrical stimulation is purposely to tone the muscle in order to replace the external
      mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may
      maintain the correction.
Spinal orthosis is an option to treat Adolescent Idiopathic Scoliosis (AIS) and is the most
      commonly used among conservative treatment. According to Scoliosis Research Society (SRS),
      orthotic treatment is indicated for AIS patients with curves greater than 25˚ but smaller
      than 45˚. However, the in-brace correction is hardly maintained and the effectiveness of
      orthotic treatment is limited, which has been an impetus to develop a more effective method
      for AIS patients to fulfill the unmet need. In order the orthosis is effective, biomechanical
      intervention and the patient compliance are two key factors. The purpose of this two-year
      project is to develop a new spinal orthosis in which an integrated system of electric surface
      stimulation and heat sensing is imbedded such that the AIS will be effectively treated with
      the mechanical orthosis plus a nocturnal use of electrical stimulation. In addition to the
      already stellar device, a totally new concept of spine erectability is proposed to provide
      evidence that can manifest the unique value of orthotic treatment as opposed to surgery. It
      is hypothesized that the new spinal orthosis would not only reduce the Cobb angle and apical
      rotation but also would strengthen the spine erectability in AIS patients. The new device
      with digital technology provides a new avenue to enable clinicians to communicate wirelessly
      with the imbedded core system such that they can adjust the electrical stimulation parameters
      and retrieve the temperature data for further compliance analysis. The smart phone and cloud
      technology can be effectively applied for both security and convenience. The electrical
      stimulation technology integrated with the total contact spinal orthosis combines the
      external correction forces on the spinal skeleton from the passive orthosis with the muscle
      forces at the lateral trunk from the stimulation process. The electrical stimulation is
      purposely to tone the muscle in order to replace the external mechanical forces gradually.
      Ultimately, when being weaned off the orthosis, patients may maintain the correction. With
      the spinal orthosis, the applied current in stimulation process would be reduced and the skin
      irritation would too. First year, there will be three tasks. An instrument will be developed
      for clinicians to assess the applicability of electrical surface stimulation to each AIS
      patient. System integration of the spinal orthosis with electrical surface stimulation and
      heat sensing will be accomplished. Clinical study of the effectiveness of passive spinal
      orthoses on 30 AIS subjects as a control group, where the Cobb angle, apical rotation and
      spine erectability will be measured before treatment and after. Second year, another 30 AIS
      patients will be recruited; the applicability of electrical surface stimulation will be
      assessed; and the new spinal orthosis will be applied to the experiment group. The Cobb
      angle, apical rotation and spine erectability will be measured before treatment and after for
      each subject. Independent t test will be carried out for the two groups to test the
      hypothesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Cobb angle
time frame: base line, 6th month and 12th month
description: When measuring Cobb angle, the investigators should identify the upper and lower end vertebra. Then, the investigators draw perpendicular lines extending along the vertebral borders. The angle where two perpendicular lines meet is called Cobb angle
measure: Change of Spine erectability
time frame: base line, 6th month and 12th month
description: Spine erectability is to define the physiological ability of the spine to maintain it erect against gravity and will be assessed without wearing orthoses.
The force F acting at the apex is the weights of the head and two upper limbs plus 7/17 trunk weight, which can be calculated with the readily available anthropometric data. The bending moment M at T8 equals the applied force F multiplies the lever arm d, which is the distance between the force and the weight line.
SE=(Weight*7/17)*d/(Cobb angle in standing-Cobb angle in supine)
measure: Change of Apical rotation
time frame: base line, 6th month and 12th month
description: Apical rotation is the degree of apical vertebral rotation .The Raimondi method uses the projection of the vertebral pedicles and the width of the vertebra as a reference for the measuring. The largest axis of the pedicle is demarcated and measured on the side of the curve convexity, and the distance of the longitudinal line from the pedicle to the border of the vertebra on the convex side is measured. Those two values are transported to the ruler, and the value of the rotation is obtained.
measure: Back muscles surface ElectroMyoGraphy (EMG)
time frame: base line, 6th month and 12th month
description: Use a non-invasive surface EMG tool to collect muscle activities on the upper and lower back area, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.
measure: Back movement pathway
time frame: base line, 6th month and 12th month
description: Use cameras to record the back motion pathway during trunk flexion-extension & lateral rotations, while the subject performs the trunk flexion-extension-lateral rotation with standing posture.
measure: Distributions of Pressure under the feet
time frame: base line, 6th month and 12th month
description: Use a flat pressure mat embedded in the walkway to collect the foot pressure distribution during static standing and dynamic walking.
measure: The nerve morphological connectivity
time frame: base line,12th month
description: The subject's diffusion tensor features are extracted from functional Magnetic Resonance Imaging of head. The features would include the never connectivity, pathway, the size of nuclei.
arm group label: ES group
arm group type: Experimental
description: Using spinal orthosis with an integrated system of electric surface stimulation and heat sensing.
arm group label: brace group
arm group type: Active Comparator
description: Using spinal orthosis BRACE
intervention type: Device
intervention name: Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing
description: The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process.
arm group label: ES group
intervention type: Device
intervention name: spinal orthosis
description: The ventrally opened total contact spinal orthosis will be designed and made of Copolymer and Aliplast. Correcting pressure points have to use the pressure pads at relevant points.
arm group label: brace group
other name: Scoliosis brace
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: TASEN WEI
role: Principal Investigator
affiliation: Changhua Christian Hospital
last name: PENGTA LIU
phone: 88647238595
phone ext: 7427
email: 105546@cch.org.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: Ta-Sen Wei,MD
investigator title: physian
mesh term: Scoliosis