xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969301</url>
    </required_header>
    <id_info>
      <org_study_id>2023-003</org_study_id>
      <nct_id>NCT05969301</nct_id>
    </id_info>
    <brief_title>Memory and Scoliosis Spinal Exercises</brief_title>
    <official_title>Role of the Memory in the Spinal Exercises for Adolescent Idiopathic Scoliosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>International Institute of Behavioral Medicines</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>International Institute of Behavioral Medicines</source>
    <oversight_info>
      <has_dmc>No</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>
        This is a behavioral observational study aimed at evaluating the impact that spinal exercises&#xD;
        exert on memory of young people. It consists of a short self-administered questionnaire which&#xD;
        will be given to adolescents with scoliosis to complete. Relationships between young&#xD;
        individuals' answers and health-related quality of life will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a behavioral observational study aimed at evaluating the impact that spinal exercises&#xD;
        exert on memory of young people. Literature found out that a memory-experience difference&#xD;
        exists between pleasant and unpleasant situations and young people are expected to capture&#xD;
        memories more accurately when these, as voiced for instance by outcome measures of&#xD;
        health-related quality of life, are at their worst- rather than at their best-perceived&#xD;
        level.&#xD;
  &#xD;
        In Literature there are not studies which investigate the relationships between the memory of&#xD;
        spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of&#xD;
        life.&#xD;
  &#xD;
        The study consists of a short self-administered questionnaire which will be given to young&#xD;
        persons to complete. In more details, the survey is made of four questions collecting&#xD;
        information on time to learn an exercise, time to perform an exercise, difficulty to do the&#xD;
        exercise, commitment to perform the exercise. Further, participants will have to complete a&#xD;
        self-administered health-related quality of life questionnaire, and namely the Scoliosis&#xD;
        Research Society-22 patients questionnaire.&#xD;
  &#xD;
        Descriptive statistics will be presented by taking into account the socio-demographic&#xD;
        characteristics of the sample being investigated. Statistical correlations between&#xD;
        adolescents' answers and health-related quality of life questionnaire will be also evaluated.&#xD;
  &#xD;
        This study's usefulness relies on understanding which spinal exercises impact more on memory&#xD;
        in order to increase a young persons' positive routines and improve their performance with&#xD;
        rehabilitative programs, with the ultimate goal of growing their adherence to and&#xD;
        satisfaction with treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>SRS-22 patient questionnaire</measure>
      <time_frame>At the moment of the assessment</time_frame>
      <description>Scoliosis Research Society-22 patient questionnaire. The maximum score in each domain (pain, function, self-image, and mental health) is 5 and minimum score is 1, with higher scores representing greater individual's quality of life.</description>
    </primary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Adolescent Idiopathic Scoliosis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Specific spinal exercises for idiopathic scoliosis</intervention_name>
      <description>The spinal esercises mainly include: active self-correction, strengthening spinal deep muscles while maintaining self-correction, segmentary stretching involving the limbs and back muscles, and postural task-oriented exercises (e.g. walking, standing, sitting).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adolescent idiopathic scoliosis, which is a three-dimensional deformity of the spine and&#xD;
          trunk occurring in healthy pubertal children.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians&#xD;
  &#xD;
            -  ability to read and understand the Italian language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any diagnosable cause of scoliosis&#xD;
  &#xD;
            -  leg-length discrepancy of &gt; 1 cm&#xD;
  &#xD;
            -  lower limb deformities interfering with spinal posture,&#xD;
  &#xD;
            -  cardiac and/or respiratory dysfunction&#xD;
  &#xD;
            -  systemic illness&#xD;
  &#xD;
            -  previous spinal surgery,&#xD;
  &#xD;
            -  cognitive impairment&#xD;
  &#xD;
            -  refusal to adhere to the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
    </eligibility>
    <results_reference>
      <citation>Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.</citation>
      <PMID>24682356</PMID>
    </results_reference>
    <results_reference>
      <citation>Monticone M, Baiardi P, Calabro D, Calabro F, Foti C. Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1412-7. doi: 10.1097/BRS.0b013e3181e88981.</citation>
      <PMID>21030889</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Health-related quality of life</keyword>
    <keyword>Adolescents</keyword>
    <keyword>Memory</keyword>
    <keyword>Scoliosis</keyword>
    <keyword>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>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969301
  org study id: 2023-003
  nct id: NCT05969301
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a behavioral observational study aimed at evaluating the impact that spinal exercises
        exert on memory of young people. It consists of a short self-administered questionnaire which
        will be given to adolescents with scoliosis to complete. Relationships between young
        individuals' answers and health-related quality of life will be evaluated.
  This is a behavioral observational study aimed at evaluating the impact that spinal exercises
        exert on memory of young people. Literature found out that a memory-experience difference
        exists between pleasant and unpleasant situations and young people are expected to capture
        memories more accurately when these, as voiced for instance by outcome measures of
        health-related quality of life, are at their worst- rather than at their best-perceived
        level.
  
        In Literature there are not studies which investigate the relationships between the memory of
        spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of
        life.
  
        The study consists of a short self-administered questionnaire which will be given to young
        persons to complete. In more details, the survey is made of four questions collecting
        information on time to learn an exercise, time to perform an exercise, difficulty to do the
        exercise, commitment to perform the exercise. Further, participants will have to complete a
        self-administered health-related quality of life questionnaire, and namely the Scoliosis
        Research Society-22 patients questionnaire.
  
        Descriptive statistics will be presented by taking into account the socio-demographic
        characteristics of the sample being investigated. Statistical correlations between
        adolescents' answers and health-related quality of life questionnaire will be also evaluated.
  
        This study's usefulness relies on understanding which spinal exercises impact more on memory
        in order to increase a young persons' positive routines and improve their performance with
        rehabilitative programs, with the ultimate goal of growing their adherence to and
        satisfaction with treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: SRS-22 patient questionnaire
  time frame: At the moment of the assessment
  description: Scoliosis Research Society-22 patient questionnaire. The maximum score in each domain (pain, function, self-image, and mental health) is 5 and minimum score is 1, with higher scores representing greater individual's quality of life.
  intervention type: Other
  intervention name: Specific spinal exercises for idiopathic scoliosis
  description: The spinal esercises mainly include: active self-correction, strengthening spinal deep muscles while maintaining self-correction, segmentary stretching involving the limbs and back muscles, and postural task-oriented exercises (e.g. walking, standing, sitting).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 19 Years
  citation: Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.
  PMID: 24682356
  citation: Monticone M, Baiardi P, Calabro D, Calabro F, Foti C. Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1412-7. doi: 10.1097/BRS.0b013e3181e88981.
  PMID: 21030889
  responsible party type: Sponsor
  mesh term: Scoliosis
  sharing ipd: No