<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/NCT03022305</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 201561</org_study_id>
    <nct_id>NCT03022305</nct_id>
  </id_info>
  <brief_title>Pelvic Alignment and Shoulder Function</brief_title>
  <official_title>The Effects of Pelvic Alignment on Shoulder Range of Motion and Torque Production</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Georgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more&#xD;
      effective in improving range of motion and torque production at the shoulder joint than&#xD;
      traditional exercises for improving hip internal rotation and adduction range of motion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current literature shows a relationship between hip joint flexibility and shoulder range of&#xD;
      motion and torque production in athletes and the general population. It is well established&#xD;
      that limited hip joint internal rotation and adduction, specifically in baseball players,&#xD;
      results in limited trunk rotation during pitching phase of throwing. Due to restricted&#xD;
      rotation range at the hip joint, athletes try to compensate for the diminished rotational&#xD;
      momentum of the trunk by producing excessive external rotation at the shoulder joint during&#xD;
      the cocking phase of throwing. Such compensation results in laxity and overstressed shoulder&#xD;
      joint structures. In the long term, increased laxity of the joint affects normal muscle&#xD;
      mechanics and results in decreased torque production at the shoulder joint.&#xD;
&#xD;
      The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more&#xD;
      effective in improving range of motion and torque production at the shoulder joint than&#xD;
      traditional exercises for improving hip internal rotation and adduction range of motion.&#xD;
&#xD;
      Group assignment:&#xD;
&#xD;
      An equal number of male and female subjects will be randomly assigned into one of three&#xD;
      groups:&#xD;
&#xD;
      Group one will have standard treatment for improving hip range of motion. Group two will&#xD;
      receive the new neuromuscular approach for improving pelvic alignment.&#xD;
&#xD;
      Group three will receive no treatment.&#xD;
&#xD;
      Participants and the examiners will be blinded to subjects' group assignment. Researchers&#xD;
      will inform the subjects that they will be randomly assigned to a group with an exercise&#xD;
      program in one of two timeframes: immediately after the initial assessment or after a&#xD;
      one-week waiting period. Subjects in the control group will wait for one week, and then they&#xD;
      will be asked to be tested one more time to make sure that the subject's physical condition&#xD;
      did not change. At this time, these subjects will be informed of participation in the control&#xD;
      group and will be given the option of going through the treatment program of choice. The&#xD;
      neuromuscular treatment will also be offered to subjects in the standard group at the&#xD;
      conclusion of the data collection period.&#xD;
&#xD;
      Testing procedures:&#xD;
&#xD;
      In a pretest session, the examiner, using a standard goniometer, will measure each&#xD;
      participant's hip flexion, extension, adduction, abduction, internal rotation, and external&#xD;
      rotation passive range of motion in seated position. Then the examiner will assess each&#xD;
      participant's pelvic alignment using the Ober test and Thomas test. Shoulder range of motion&#xD;
      will also be assessed using the standard goniometry procedures in the seated position.&#xD;
      Shoulder torque production will be assessed using a Biodex isokinetic dynamometer.&#xD;
&#xD;
      The following parameters will be assessed using standard physical therapy techniques:&#xD;
&#xD;
      Hip Joint Assessment Hip range of motion assessment Hip Flexion Hip Extension Hip abduction&#xD;
      Hip adduction Hip internal rotation Hip external rotation Ober test: [While the lower&#xD;
      extremity is still neutral in the transverse plane, the examiner will allow the leg to slowly&#xD;
      be lowered into full adduction. The test is considered positive if the knee joint does not&#xD;
      reach the examination table. This test will be conducted for both sides.] Thomas test: [While&#xD;
      holding the flexed knee to the chest, the participant will slowly lie back into a supine&#xD;
      position on the examination table with the opposite leg hanging freely over the edge of the&#xD;
      table. The test is considered positive if the free hanging leg is raised off the table with&#xD;
      subject lying in supine position. This test will be conducted for both lower extremities.]&#xD;
      Shoulder Joint Assessment Shoulder range of motion assessment Shoulder Flexion Shoulder&#xD;
      Extension Shoulder Abduction Shoulder Internal Rotation Shoulder External Rotation Assessment&#xD;
      of shoulder torque production: [Assessed by a Biodex isokinetic dynamometer.]&#xD;
&#xD;
      Treatment procedures:&#xD;
&#xD;
      Treatment procedure for group one:&#xD;
&#xD;
      Subjects in the standard treatment group will perform 10 repetitions of active hip internal&#xD;
      rotation, external rotation, abduction, adduction, flexion and extension exercises daily,&#xD;
      under supervision of the treating therapist.&#xD;
&#xD;
      Treatment neuromuscular training for group two:&#xD;
&#xD;
      Subjects in this group will perform the neuromuscular treatment for pelvic alignment, as&#xD;
      suggested by Postural Restoration Institute, once a day under treating therapist supervision&#xD;
      for one week. Subject will flex the hip and knee joints to 90° and will rest both feet&#xD;
      against the wall with a standard 4 - 6&quot; ball will be placed between the subject's knees. At&#xD;
      this position, the subject is instructed to squeeze the ball between the knees and to perform&#xD;
      an isometric hamstring muscle contraction (statically pulling the feet downward without&#xD;
      pressing to the wall). At this point, the subject will be instructed to perform a gentle&#xD;
      posterior pelvic tilt while avoiding abdominal muscle contraction. While maintaining this&#xD;
      position, the subject is instructed to take a deep breath in through the nose and then slowly&#xD;
      blow out into the balloon. The subject will be instructed to pause for 3 seconds while&#xD;
      pressing the tongue to the roof the mouth to prevent airflow out of the balloon. After the&#xD;
      4th breath in, the subject will pinch the neck of the balloon and remove it from the mouth.&#xD;
      Then subject will relax and take the feet off the wall. This exercise will be repeated daily&#xD;
      for one week (Monday through Friday). Following neuromuscular training exercise, the patient&#xD;
      will perform a coordinated hip internal and external rotation exercise in side lying.&#xD;
&#xD;
      The no treatment group will act as a control group. Both the standard and no treatment group&#xD;
      will be offered free neuromuscular treatment at the conclusion of posttest data collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic realignment achieved as indicated by negative Ober test on examination at completion of the training period..</measure>
    <time_frame>Outcomes will be assessed following one week for each of the therapy groups.</time_frame>
    <description>Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic realignment achieved as indicated by negative Thomas test on examination at completion of the training period..</measure>
    <time_frame>Outcomes will be assessed following one week for each of the therapy groups.</time_frame>
    <description>Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hip Alignment and Shoulder Rotation</condition>
  <arm_group>
    <arm_group_label>Group one - standard therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard physical therapy treatment for shoulder and hip malalignment will be administered for one week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group two - neuromuscular therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental neuromuscular physical therapy treatment for shoulder and hip malalignment will be administered for one week. This therapy is exercised based.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group three - no treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No physical therapy treatment will be given to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group one - standard therapy</intervention_name>
    <description>Group two - standard physical therapy treatment for shoulder and hip maladjustment.</description>
    <arm_group_label>Group one - standard therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group two - neuromuscular therapy</intervention_name>
    <description>Use of physical therapy treatment for shoulder and hip maladjustment.</description>
    <arm_group_label>Group two - neuromuscular therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria includes:&#xD;
&#xD;
               -  College-aged students between the ages of 18 and 25,&#xD;
&#xD;
               -  Having limited hip ROM than the normal ranges suggested by the AAOS guidelines,&#xD;
&#xD;
               -  Having positive Ober and Thomas tests,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria is as follows:&#xD;
&#xD;
               -  Having known shoulder pathologies,&#xD;
&#xD;
               -  Structural leg length discrepancies,&#xD;
&#xD;
               -  Having any cardiovascular, respiratory or other health problems&#xD;
&#xD;
               -  Require use of an assistive device for ambulation,&#xD;
&#xD;
               -  Amputees, and people with structural deformities of the shoulder or hip joint.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reza Nourbakhsh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Georgia</affiliation>
  </overall_official>
  <reference>
    <citation>Robb AJ, Fleisig G, Wilk K, Macrina L, Bolt B, Pajaczkowski J. Passive ranges of motion of the hips and their relationship with pitching biomechanics and ball velocity in professional baseball pitchers. Am J Sports Med. 2010 Dec;38(12):2487-93. doi: 10.1177/0363546510375535. Epub 2010 Aug 31.</citation>
    <PMID>20807860</PMID>
  </reference>
  <reference>
    <citation>Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, Gremeaux V. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011 Aug;20(3):367-83. doi: 10.1123/jsr.20.3.367.</citation>
    <PMID>21828388</PMID>
  </reference>
  <reference>
    <citation>Baltaci G, Tunay VB. Isokinetic performance at diagonal pattern and shoulder mobility in elite overhead athletes. Scand J Med Sci Sports. 2004 Aug;14(4):231-8. doi: 10.1111/j.1600-0838.2004.00348.x.</citation>
    <PMID>15265145</PMID>
  </reference>
  <results_reference>
    <citation>Laudner K, Wong R, Onuki T, Lynall R, Meister K. The relationship between clinically measured hip rotational motion and shoulder biomechanics during the pitching motion. J Sci Med Sport. 2015 Sep;18(5):581-4. doi: 10.1016/j.jsams.2014.07.011. Epub 2014 Jul 30.</citation>
    <PMID>25130280</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip alignment</keyword>
  <keyword>Hip misalignment</keyword>
  <keyword>Shoulder function</keyword>
  <keyword>Shoulder rotation</keyword>
  <keyword>Athletic shoulder injuries</keyword>
  <keyword>Athletic hip alignment</keyword>
  <keyword>Hip and shoulder alignment</keyword>
  <keyword>Hip joint</keyword>
  <keyword>Hip joint alignment</keyword>
  <keyword>Hip joint misalignment</keyword>
  <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/NCT03022305
org study id: IRB 201561
nct id: NCT03022305
lead sponsor: 
has dmc: No
The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more
      effective in improving range of motion and torque production at the shoulder joint than
      traditional exercises for improving hip internal rotation and adduction range of motion.
Current literature shows a relationship between hip joint flexibility and shoulder range of
      motion and torque production in athletes and the general population. It is well established
      that limited hip joint internal rotation and adduction, specifically in baseball players,
      results in limited trunk rotation during pitching phase of throwing. Due to restricted
      rotation range at the hip joint, athletes try to compensate for the diminished rotational
      momentum of the trunk by producing excessive external rotation at the shoulder joint during
      the cocking phase of throwing. Such compensation results in laxity and overstressed shoulder
      joint structures. In the long term, increased laxity of the joint affects normal muscle
      mechanics and results in decreased torque production at the shoulder joint.

      The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more
      effective in improving range of motion and torque production at the shoulder joint than
      traditional exercises for improving hip internal rotation and adduction range of motion.

      Group assignment:

      An equal number of male and female subjects will be randomly assigned into one of three
      groups:

      Group one will have standard treatment for improving hip range of motion. Group two will
      receive the new neuromuscular approach for improving pelvic alignment.

      Group three will receive no treatment.

      Participants and the examiners will be blinded to subjects' group assignment. Researchers
      will inform the subjects that they will be randomly assigned to a group with an exercise
      program in one of two timeframes: immediately after the initial assessment or after a
      one-week waiting period. Subjects in the control group will wait for one week, and then they
      will be asked to be tested one more time to make sure that the subject's physical condition
      did not change. At this time, these subjects will be informed of participation in the control
      group and will be given the option of going through the treatment program of choice. The
      neuromuscular treatment will also be offered to subjects in the standard group at the
      conclusion of the data collection period.

      Testing procedures:

      In a pretest session, the examiner, using a standard goniometer, will measure each
      participant's hip flexion, extension, adduction, abduction, internal rotation, and external
      rotation passive range of motion in seated position. Then the examiner will assess each
      participant's pelvic alignment using the Ober test and Thomas test. Shoulder range of motion
      will also be assessed using the standard goniometry procedures in the seated position.
      Shoulder torque production will be assessed using a Biodex isokinetic dynamometer.

      The following parameters will be assessed using standard physical therapy techniques:

      Hip Joint Assessment Hip range of motion assessment Hip Flexion Hip Extension Hip abduction
      Hip adduction Hip internal rotation Hip external rotation Ober test: [While the lower
      extremity is still neutral in the transverse plane, the examiner will allow the leg to slowly
      be lowered into full adduction. The test is considered positive if the knee joint does not
      reach the examination table. This test will be conducted for both sides.] Thomas test: [While
      holding the flexed knee to the chest, the participant will slowly lie back into a supine
      position on the examination table with the opposite leg hanging freely over the edge of the
      table. The test is considered positive if the free hanging leg is raised off the table with
      subject lying in supine position. This test will be conducted for both lower extremities.]
      Shoulder Joint Assessment Shoulder range of motion assessment Shoulder Flexion Shoulder
      Extension Shoulder Abduction Shoulder Internal Rotation Shoulder External Rotation Assessment
      of shoulder torque production: [Assessed by a Biodex isokinetic dynamometer.]

      Treatment procedures:

      Treatment procedure for group one:

      Subjects in the standard treatment group will perform 10 repetitions of active hip internal
      rotation, external rotation, abduction, adduction, flexion and extension exercises daily,
      under supervision of the treating therapist.

      Treatment neuromuscular training for group two:

      Subjects in this group will perform the neuromuscular treatment for pelvic alignment, as
      suggested by Postural Restoration Institute, once a day under treating therapist supervision
      for one week. Subject will flex the hip and knee joints to 90° and will rest both feet
      against the wall with a standard 4 - 6" ball will be placed between the subject's knees. At
      this position, the subject is instructed to squeeze the ball between the knees and to perform
      an isometric hamstring muscle contraction (statically pulling the feet downward without
      pressing to the wall). At this point, the subject will be instructed to perform a gentle
      posterior pelvic tilt while avoiding abdominal muscle contraction. While maintaining this
      position, the subject is instructed to take a deep breath in through the nose and then slowly
      blow out into the balloon. The subject will be instructed to pause for 3 seconds while
      pressing the tongue to the roof the mouth to prevent airflow out of the balloon. After the
      4th breath in, the subject will pinch the neck of the balloon and remove it from the mouth.
      Then subject will relax and take the feet off the wall. This exercise will be repeated daily
      for one week (Monday through Friday). Following neuromuscular training exercise, the patient
      will perform a coordinated hip internal and external rotation exercise in side lying.

      The no treatment group will act as a control group. Both the standard and no treatment group
      will be offered free neuromuscular treatment at the conclusion of posttest data collection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pelvic realignment achieved as indicated by negative Ober test on examination at completion of the training period..
time frame: Outcomes will be assessed following one week for each of the therapy groups.
description: Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.
measure: Pelvic realignment achieved as indicated by negative Thomas test on examination at completion of the training period..
time frame: Outcomes will be assessed following one week for each of the therapy groups.
description: Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.
arm group label: Group one - standard therapy
arm group type: Experimental
description: Standard physical therapy treatment for shoulder and hip malalignment will be administered for one week.
arm group label: Group two - neuromuscular therapy
arm group type: Experimental
description: Experimental neuromuscular physical therapy treatment for shoulder and hip malalignment will be administered for one week. This therapy is exercised based.
arm group label: Group three - no treatment
arm group type: No Intervention
description: No physical therapy treatment will be given to this group.
intervention type: Behavioral
intervention name: Group one - standard therapy
description: Group two - standard physical therapy treatment for shoulder and hip maladjustment.
arm group label: Group one - standard therapy
intervention type: Behavioral
intervention name: Group two - neuromuscular therapy
description: Use of physical therapy treatment for shoulder and hip maladjustment.
arm group label: Group two - neuromuscular therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Reza Nourbakhsh, PhD
role: Principal Investigator
affiliation: University of North Georgia
citation: Robb AJ, Fleisig G, Wilk K, Macrina L, Bolt B, Pajaczkowski J. Passive ranges of motion of the hips and their relationship with pitching biomechanics and ball velocity in professional baseball pitchers. Am J Sports Med. 2010 Dec;38(12):2487-93. doi: 10.1177/0363546510375535. Epub 2010 Aug 31.
PMID: 20807860
citation: Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, Gremeaux V. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011 Aug;20(3):367-83. doi: 10.1123/jsr.20.3.367.
PMID: 21828388
citation: Baltaci G, Tunay VB. Isokinetic performance at diagonal pattern and shoulder mobility in elite overhead athletes. Scand J Med Sci Sports. 2004 Aug;14(4):231-8. doi: 10.1111/j.1600-0838.2004.00348.x.
PMID: 15265145
citation: Laudner K, Wong R, Onuki T, Lynall R, Meister K. The relationship between clinically measured hip rotational motion and shoulder biomechanics during the pitching motion. J Sci Med Sport. 2015 Sep;18(5):581-4. doi: 10.1016/j.jsams.2014.07.011. Epub 2014 Jul 30.
PMID: 25130280
responsible party type: Sponsor
sharing ipd: No