<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/NCT02190331</url>
  </required_header>
  <id_info>
    <org_study_id>SFRH/BD/77633/2011</org_study_id>
    <nct_id>NCT02190331</nct_id>
  </id_info>
  <brief_title>Effects of a Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Posture Adolescents</brief_title>
  <official_title>The Effects of Training and Detraining After an 8 Month Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Postures in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Motricidade Humana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Motricidade Humana</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To evaluate the effects of a 32-weeks resistance and stretching training program applied&#xD;
           in Physical Education classes on forward head and protracted shoulder Portuguese&#xD;
           adolescents (15-17 years old).&#xD;
&#xD;
        -  To evaluate on adolescents submitted to strength and stretching exercises the effects of&#xD;
           a 16-week detraining period after the end of the intervention protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized and controlled study will be conducted over a 12 month period, with&#xD;
      adolescents of two public secondary schools, in Lisbon.&#xD;
&#xD;
      At the beginning, a total of 275 adolescent students aged 15-17 years old will be evaluated&#xD;
      with photogrammetry. The students will be screened by measuring the cervical (CV) and&#xD;
      shoulder (SH) angle with photogrammetry. If the CV and SH angle were less than 50º and 52º&#xD;
      respectively, the adolescent was considered to have forward head posture (FHP) and protracted&#xD;
      shoulder (PS) and was selected to the study.&#xD;
&#xD;
      Participants will be excluded if their CV and SH angle was equal or higher than 50º and 52º&#xD;
      respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal&#xD;
      pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were&#xD;
      non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic&#xD;
      kyphosis.&#xD;
&#xD;
      After these the eligible students will be randomly assigned to the control or interventional&#xD;
      group. The intervention group will begin a 32-week stretching and strengthening program to be&#xD;
      performed in the last part of the Physical Education (PE) classes. The control group will&#xD;
      only participate in the PE classes. Since the 32th week until the 48th week the experimental&#xD;
      group will not follow the interventional training program and both groups will only&#xD;
      participate in PE classes.&#xD;
&#xD;
      The program will be constituted by four strengthening exercises and three stretching&#xD;
      exercises and is designed based on the assumption that the use of therapeutic exercise is&#xD;
      effective in the correction of specific neck and shoulder postures. The training exercise&#xD;
      protocol will be designed for the correction of the FHP and PS, targeting to the selective&#xD;
      activation of lower trapezius, middle trapezius and rhomboids, to the lengthening of the&#xD;
      pectoralis major, pectoralis minor and sternocleidomastoid and to the improvement of the deep&#xD;
      cervical flexor function This program is going to be applied in the last 15-20 minutes of&#xD;
      each PE class, twice a week, with the supervision and help of the PE teacher.&#xD;
&#xD;
      The postural assessment of the groups will be performed in the beginning and after 36 and&#xD;
      48-weeks intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in postural angles (cervical and shoulder angle)</measure>
    <time_frame>36 and 48 weeks</time_frame>
    <description>We will assess the Cervical angle - the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear and the shoulder angle - The angle formed at the intersection of the line between the midpoint of the humerus and the spinous process of C7 and the horizontal line through the midpoint of the humerus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the American Shoulder and Elbow Surgeons Standardized questionnaire</measure>
    <time_frame>36 and 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">275</enrollment>
  <condition>Posture Disorders in Children</condition>
  <arm_group>
    <arm_group_label>Interventional program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training protocol is constituted by 4 strengthening exercises (Side Lying External Rotation, Prone Horizontal Abduction with External Rotation, Y to I exercise and Chin Tuck) and 3 stretching exercises(one- Sided Unilateral Self Stretch Exercise, one-sided Unilateral Self Stretch Exercise, Static Sternocleidomastoid Stretch and Static Levator Scapulae Stretch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will only participate in the Physical Education classes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interventional program postural correction training</intervention_name>
    <description>The postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.</description>
    <arm_group_label>Interventional program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group physical education classes</intervention_name>
    <description>Only performed the physical education classes</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        adolescents with 15-17 years old with cervical angle lower than 50º and the shoulder angle&#xD;
        lower than 52º&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded if their CV and SH angle was equal or higher than 50º and 52º&#xD;
        respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal&#xD;
        pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were&#xD;
        non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic&#xD;
        kyphosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo Ruivo, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lisbon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technical University of Lisbon</name>
      <address>
        <city>Lisbon,</city>
        <state>Cruz Quebrada-Dafundo</state>
        <zip>1499-002</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Motricidade Humana</investigator_affiliation>
    <investigator_full_name>Rodrigo Ruivo</investigator_full_name>
    <investigator_title>Mr Rodrigo Ruivo</investigator_title>
  </responsible_party>
  <keyword>Detraining</keyword>
  <keyword>Neck</keyword>
  <keyword>Exercise</keyword>
  <keyword>Posture</keyword>
  <keyword>Rehabilitation</keyword>
  <!-- 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/NCT02190331
org study id: SFRH/BD/77633/2011
nct id: NCT02190331
lead sponsor: 
has dmc: Yes
-  To evaluate the effects of a 32-weeks resistance and stretching training program applied
           in Physical Education classes on forward head and protracted shoulder Portuguese
           adolescents (15-17 years old).

        -  To evaluate on adolescents submitted to strength and stretching exercises the effects of
           a 16-week detraining period after the end of the intervention protocol.
A prospective, randomized and controlled study will be conducted over a 12 month period, with
      adolescents of two public secondary schools, in Lisbon.

      At the beginning, a total of 275 adolescent students aged 15-17 years old will be evaluated
      with photogrammetry. The students will be screened by measuring the cervical (CV) and
      shoulder (SH) angle with photogrammetry. If the CV and SH angle were less than 50º and 52º
      respectively, the adolescent was considered to have forward head posture (FHP) and protracted
      shoulder (PS) and was selected to the study.

      Participants will be excluded if their CV and SH angle was equal or higher than 50º and 52º
      respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal
      pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were
      non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic
      kyphosis.

      After these the eligible students will be randomly assigned to the control or interventional
      group. The intervention group will begin a 32-week stretching and strengthening program to be
      performed in the last part of the Physical Education (PE) classes. The control group will
      only participate in the PE classes. Since the 32th week until the 48th week the experimental
      group will not follow the interventional training program and both groups will only
      participate in PE classes.

      The program will be constituted by four strengthening exercises and three stretching
      exercises and is designed based on the assumption that the use of therapeutic exercise is
      effective in the correction of specific neck and shoulder postures. The training exercise
      protocol will be designed for the correction of the FHP and PS, targeting to the selective
      activation of lower trapezius, middle trapezius and rhomboids, to the lengthening of the
      pectoralis major, pectoralis minor and sternocleidomastoid and to the improvement of the deep
      cervical flexor function This program is going to be applied in the last 15-20 minutes of
      each PE class, twice a week, with the supervision and help of the PE teacher.

      The postural assessment of the groups will be performed in the beginning and after 36 and
      48-weeks intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: change in postural angles (cervical and shoulder angle)
time frame: 36 and 48 weeks
description: We will assess the Cervical angle - the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear and the shoulder angle - The angle formed at the intersection of the line between the midpoint of the humerus and the spinous process of C7 and the horizontal line through the midpoint of the humerus.
measure: the American Shoulder and Elbow Surgeons Standardized questionnaire
time frame: 36 and 48 weeks
arm group label: Interventional program
arm group type: Experimental
description: The training protocol is constituted by 4 strengthening exercises (Side Lying External Rotation, Prone Horizontal Abduction with External Rotation, Y to I exercise and Chin Tuck) and 3 stretching exercises(one- Sided Unilateral Self Stretch Exercise, one-sided Unilateral Self Stretch Exercise, Static Sternocleidomastoid Stretch and Static Levator Scapulae Stretch
arm group label: Control group
arm group type: Active Comparator
description: The control group will only participate in the Physical Education classes
intervention type: Other
intervention name: Interventional program postural correction training
description: The postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
arm group label: Interventional program
intervention type: Other
intervention name: Control Group physical education classes
description: Only performed the physical education classes
arm group label: Control group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 17 Years
healthy volunteers: No
last name: Rodrigo Ruivo, Master
role: Principal Investigator
affiliation: University of Lisbon
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Faculdade de Motricidade Humana
investigator full name: Rodrigo Ruivo
investigator title: Mr Rodrigo Ruivo