<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/NCT01711203</url>
  </required_header>
  <id_info>
    <org_study_id>Spondy 12-35</org_study_id>
    <nct_id>NCT01711203</nct_id>
  </id_info>
  <brief_title>The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis</brief_title>
  <official_title>The Addition of a Pilates Program for Short-Term Improvements in Self Report and Physical Functions With Patients With Spondylolysis or Spondylolisthesis: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Megan Donaldson PT, PhD, FAAOMPT</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Akron Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Walsh University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a&#xD;
      multimodal strengthening program, for patients under the age of 21, who have spondylolysis&#xD;
      and/or spondylolisthesis.&#xD;
&#xD;
      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in&#xD;
      children and adolescents presenting with low back pain.&#xD;
&#xD;
      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with&#xD;
      functional performance test measures, exercise logs, adherence scale for patient and parent&#xD;
      perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry&#xD;
      Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be&#xD;
      randomized into two groups: bracing and a general strengthening program vs. bracing and a&#xD;
      Pilates/motor learning program combined with a general strengthening program.&#xD;
&#xD;
      This study will begin with an initial examination and continue with treatment sessions&#xD;
      2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing&#xD;
      the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome&#xD;
      measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Location: Akron Children's Hospital, Sports Medicine. For research purposes, the study will&#xD;
      conclude at the end of the 6 weeks, however, if the patient has not met their physical&#xD;
      therapy goals, then physical therapy may continue upon collaboration with the patient and&#xD;
      his/her parents (if a minor), physical therapist, and referring physician.&#xD;
&#xD;
      Initially, there will be a letter to discuss the opportunity to participate in the research&#xD;
      study within initial intake paperwork. This will allow the patient and parent to have some&#xD;
      preliminary information prior to consulting with the therapist. As is customary, the patient&#xD;
      will be assigned to a licensed PT for the initial examination. The initial examining&#xD;
      therapist will be responsible to discuss and provide the patient with the pre-enrollment&#xD;
      information and informed consent (estimation of time needed approximately 15 minutes) and may&#xD;
      obtain consent any time after the pre-enrollment discussion or until the start of the&#xD;
      patient's second session. Upon agreement of participation in the study, the patient will be&#xD;
      able to complete the additional paperwork required as part of the study (outcome measures).&#xD;
      The patient will be randomized after self-inclusion in to the study into one of two groups by&#xD;
      role of dice where 1, 3, 5 is the intervention group and 2, 4, 6 is the clinical control&#xD;
      group.&#xD;
&#xD;
      The initial examination will include a subjective history taking, and objective assessment&#xD;
      with physical testing of the spine including active range of motion, passive range of motion,&#xD;
      strength assessment/endurance assessment of the lumbar musculature. The examination will take&#xD;
      approximately 45 minutes to 1 hour in length.&#xD;
&#xD;
      Description of Subjects (include age range, selection criteria, recruitment procedures,&#xD;
      anticipated and desired sample size)-&#xD;
&#xD;
      Subjects of the ages 8-21 are eligible to participate in this study. Due to the inclusion of&#xD;
      a vulnerable subject the responsible party/parent or guardian must grant inclusion and must&#xD;
      be able to attend the initial physical therapy evaluation of the minor and sign all&#xD;
      consenting documents. The physician offices within the surrounding hospital area and doctors&#xD;
      that typically refer to this clinic will be notified of the research study (attachment&#xD;
      physician letter and flyer for the facility). Patients will be included in the study if they&#xD;
      meet the following criteria:&#xD;
&#xD;
        1. Age of subject must be between 8-21 years old&#xD;
&#xD;
        2. Ability to read and understand the English language&#xD;
&#xD;
        3. Parent/caregiver consent&#xD;
&#xD;
        4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician with&#xD;
           or without imaging.&#xD;
&#xD;
      The investigators plan to target a maximum of 120 subjects for the large study, allowing a&#xD;
      20% drop out rate. This study is powered at n=100 subjects for at least a minimal effect to&#xD;
      be calculated.&#xD;
&#xD;
      The investigators hypothesize a minimal effect on the patient group who receives the&#xD;
      investigational &quot;motor control&quot; or Pilates based exercise compared to the general core&#xD;
      strengthening program patient group.&#xD;
&#xD;
      Outcome Measures:&#xD;
&#xD;
      Numeric Pain Rating Scale&#xD;
&#xD;
      The numeric pain rating scale (NPRS) was used to capture the patient's level of pain.&#xD;
      Patients were asked to indicate the intensity of current, best, and worst levels of pain over&#xD;
      the past 24 hours using an 11-point scale ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst pain&#xD;
      imaginable&quot;). The average of the three ratings was used to represent the patient's level of&#xD;
      pain over the previous 24 hours. This procedure has been shown to have adequate reliability,&#xD;
      validity, and responsiveness in patients with LBP and has a minimally clinical important&#xD;
      difference of 2-point change in patients with mechanical low back pain.&#xD;
&#xD;
      Global Rating of Change Scale&#xD;
&#xD;
      At the follow-up evaluation, each patient will complete a global rating of change (GROC).&#xD;
      Patients will rate their overall perception of improvement since beginning treatment on a&#xD;
      scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great&#xD;
      deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent&#xD;
      small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7&#xD;
      large changes.&#xD;
&#xD;
      The Modified Oswestry Disability Questionnaire (ODI)&#xD;
&#xD;
      The Modified ODI is a self-administered questionnaire that requires 5 minutes to complete and&#xD;
      1 minute to score. Scores are associated with degree of disability ranging from minimal to&#xD;
      bedbound. The ODI is a condition-specific disability scale for patients with LBP, consisting&#xD;
      of 10 items addressing different aspects of function, each scored from 0-5 with higher values&#xD;
      representing greater disability. This modified ODI has been found to have high levels of&#xD;
      reliability, validity, and responsiveness. The MCID for the ODI has been identified at six&#xD;
      points .On this scale, 0-20 equates to minimal disability, 20-40 moderate disability, 40-60&#xD;
      severe disability, 60-80 crippled, and 80-100 bed-bound or exaggerating.&#xD;
&#xD;
      Physical Endurance Tests/Measures McGill has established a performance test to examine the&#xD;
      endurance profiles of healthy young men and women for the spine stabilizing musculature.&#xD;
      Given the growing support for quantification of endurance, these data of endurance times and&#xD;
      their ratios between extensor, flexor, and lateral flexor groups in healthy normal subjects&#xD;
      are useful for patient evaluation and for providing clinical training targets. To establish&#xD;
      isometric endurance holding times, as well as ratios between torso extensors, flexors, and&#xD;
      lateral flexors (stabilizers), for clinical assessment and rehabilitation targets. The tests&#xD;
      proved reliable, with reliability coefficients of &gt;.97 for the repeated tests on 5&#xD;
      consecutive days and again 8 weeks later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global Rating of Change Scale</measure>
    <time_frame>3 and 6 weeks and 3 months post discharge</time_frame>
    <description>Patients will rate their overall perception of improvement since beginning treatment on a scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7 large changes .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Oswestry Disability Index</measure>
    <time_frame>Initial evaluation, 3 and 6 weeks and 3 months post discharge</time_frame>
    <description>The Modified ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score. Scores are associated with degree of disability ranging from minimal to bedbound. The ODI is a condition-specific disability scale for patients with LBP, consisting of 10 items addressing different aspects of function, each scored from 0-5 with higher values representing greater disability. This modified ODI has been found to have high levels of reliability, validity, and responsiveness . The MCID for the ODI has been identified at six points .On this scale, 0-20 equates to minimal disability, 20-40 moderate disability, 40-60 severe disability, 60-80 crippled, and 80-100 bed-bound or exaggerating.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>McGill's Physical Endurance Test Cluster</measure>
    <time_frame>Initial evaluation, 3 weeks and 6 weeks</time_frame>
    <description>McGill has established a performance test to examine the endurance profiles of healthy young men and women for the spine stabilizing musculature . Given the growing support for quantification of endurance, these data of endurance times and their ratios between extensor, flexor, and lateral flexor groups in healthy normal subjects are useful for patient evaluation and for providing clinical training targets. To establish isometric endurance holding times, as well as ratios between torso extensors, flexors, and lateral flexors (stabilizers), for clinical assessment and rehabilitation targets. The tests proved reliable, with reliability coefficients of &gt;.97 for the repeated tests on 5 consecutive days and again 8 weeks later.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Spondylolisthesis</condition>
  <condition>Spondylolysis</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Motor Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pilates-based exercise with verbal cues to facilitate motor control Plank progression, use of feedback tool VERBAL CUES FOR MOTOR CONTROL GROUP (could also include above cues) &quot;Maintain neutral spine&quot; &quot;Not too arched, not too flexed&quot; &quot;Remember your pilates position&quot; &quot;Inhale, exhale&quot; &quot;Let me hear your breath&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General strengthening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient group that will receive active strengthening without specific verbal cueing to recruit deeper abdominal musculature. Core strengthening and lower quarter strengthening is the focus of this group.&#xD;
Verbal cuing will include:&#xD;
VERBAL CUEING FOR NON-MOTOR CONTROL GROUP&#xD;
&quot;Keep your back straight&quot; &quot;Don't slouch&quot; &quot;Don't arch your back&quot; &quot;Don't let your body move&quot; &quot;Nothing should move but your arms&quot; &quot;tighten up your abs&quot; &quot;suck in your stomach&quot; &quot;feet shoulder-width apart, knees bent, shoulders back, hold your stomach tight&quot; Time will be kept the same as the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motor Control</intervention_name>
    <description>Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.</description>
    <arm_group_label>Motor Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General Strengthening</intervention_name>
    <description>General abdominal and lower quarter musculature strengthening</description>
    <arm_group_label>General strengthening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of subject must be between 8-21 years old&#xD;
&#xD;
          2. Ability to read and understand the English language&#xD;
&#xD;
          3. Parent/caregiver attendance and consent for initial evaluation&#xD;
&#xD;
          4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician with&#xD;
             or without imaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not meeting the inclusion criteria&#xD;
&#xD;
          2. Not able to attend therapy 2x's per week&#xD;
&#xD;
          3. If physician prescription requests only physical bracing as rendered treatment&#xD;
&#xD;
          4. If patient presents with signs of neurological compromise&#xD;
&#xD;
          5. Red flags during the medical screening that would require the patient to see the&#xD;
             physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan B Donaldson, PT PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Walsh University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dreisinger TE, Nelson B. Management of back pain in athletes. Sports Med. 1996 Apr;21(4):313-20. doi: 10.2165/00007256-199621040-00006.</citation>
    <PMID>8726348</PMID>
  </reference>
  <reference>
    <citation>Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.</citation>
    <PMID>19352240</PMID>
  </reference>
  <reference>
    <citation>Cavalier R, Herman MJ, Cheung EV, Pizzutillo PD. Spondylolysis and spondylolisthesis in children and adolescents: I. Diagnosis, natural history, and nonsurgical management. J Am Acad Orthop Surg. 2006 Jul;14(7):417-24. doi: 10.5435/00124635-200607000-00004.</citation>
    <PMID>16822889</PMID>
  </reference>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>January 18, 2015</last_update_submitted>
  <last_update_submitted_qc>January 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Walsh University</investigator_affiliation>
    <investigator_full_name>Megan Donaldson PT, PhD, FAAOMPT</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Spondylolysis</keyword>
  <keyword>Spondylolisthesis</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Spondylolysis</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/NCT01711203
org study id: Spondy 12-35
nct id: NCT01711203
lead sponsor: 
collaborator: 
has dmc: No
Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a
      multimodal strengthening program, for patients under the age of 21, who have spondylolysis
      and/or spondylolisthesis.

      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in
      children and adolescents presenting with low back pain.

      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with
      functional performance test measures, exercise logs, adherence scale for patient and parent
      perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry
      Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be
      randomized into two groups: bracing and a general strengthening program vs. bracing and a
      Pilates/motor learning program combined with a general strengthening program.

      This study will begin with an initial examination and continue with treatment sessions
      2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing
      the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome
      measures.
Location: Akron Children's Hospital, Sports Medicine. For research purposes, the study will
      conclude at the end of the 6 weeks, however, if the patient has not met their physical
      therapy goals, then physical therapy may continue upon collaboration with the patient and
      his/her parents (if a minor), physical therapist, and referring physician.

      Initially, there will be a letter to discuss the opportunity to participate in the research
      study within initial intake paperwork. This will allow the patient and parent to have some
      preliminary information prior to consulting with the therapist. As is customary, the patient
      will be assigned to a licensed PT for the initial examination. The initial examining
      therapist will be responsible to discuss and provide the patient with the pre-enrollment
      information and informed consent (estimation of time needed approximately 15 minutes) and may
      obtain consent any time after the pre-enrollment discussion or until the start of the
      patient's second session. Upon agreement of participation in the study, the patient will be
      able to complete the additional paperwork required as part of the study (outcome measures).
      The patient will be randomized after self-inclusion in to the study into one of two groups by
      role of dice where 1, 3, 5 is the intervention group and 2, 4, 6 is the clinical control
      group.

      The initial examination will include a subjective history taking, and objective assessment
      with physical testing of the spine including active range of motion, passive range of motion,
      strength assessment/endurance assessment of the lumbar musculature. The examination will take
      approximately 45 minutes to 1 hour in length.

      Description of Subjects (include age range, selection criteria, recruitment procedures,
      anticipated and desired sample size)-

      Subjects of the ages 8-21 are eligible to participate in this study. Due to the inclusion of
      a vulnerable subject the responsible party/parent or guardian must grant inclusion and must
      be able to attend the initial physical therapy evaluation of the minor and sign all
      consenting documents. The physician offices within the surrounding hospital area and doctors
      that typically refer to this clinic will be notified of the research study (attachment
      physician letter and flyer for the facility). Patients will be included in the study if they
      meet the following criteria:

        1. Age of subject must be between 8-21 years old

        2. Ability to read and understand the English language

        3. Parent/caregiver consent

        4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician with
           or without imaging.

      The investigators plan to target a maximum of 120 subjects for the large study, allowing a
      20% drop out rate. This study is powered at n=100 subjects for at least a minimal effect to
      be calculated.

      The investigators hypothesize a minimal effect on the patient group who receives the
      investigational "motor control" or Pilates based exercise compared to the general core
      strengthening program patient group.

      Outcome Measures:

      Numeric Pain Rating Scale

      The numeric pain rating scale (NPRS) was used to capture the patient's level of pain.
      Patients were asked to indicate the intensity of current, best, and worst levels of pain over
      the past 24 hours using an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain
      imaginable"). The average of the three ratings was used to represent the patient's level of
      pain over the previous 24 hours. This procedure has been shown to have adequate reliability,
      validity, and responsiveness in patients with LBP and has a minimally clinical important
      difference of 2-point change in patients with mechanical low back pain.

      Global Rating of Change Scale

      At the follow-up evaluation, each patient will complete a global rating of change (GROC).
      Patients will rate their overall perception of improvement since beginning treatment on a
      scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great
      deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent
      small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7
      large changes.

      The Modified Oswestry Disability Questionnaire (ODI)

      The Modified ODI is a self-administered questionnaire that requires 5 minutes to complete and
      1 minute to score. Scores are associated with degree of disability ranging from minimal to
      bedbound. The ODI is a condition-specific disability scale for patients with LBP, consisting
      of 10 items addressing different aspects of function, each scored from 0-5 with higher values
      representing greater disability. This modified ODI has been found to have high levels of
      reliability, validity, and responsiveness. The MCID for the ODI has been identified at six
      points .On this scale, 0-20 equates to minimal disability, 20-40 moderate disability, 40-60
      severe disability, 60-80 crippled, and 80-100 bed-bound or exaggerating.

      Physical Endurance Tests/Measures McGill has established a performance test to examine the
      endurance profiles of healthy young men and women for the spine stabilizing musculature.
      Given the growing support for quantification of endurance, these data of endurance times and
      their ratios between extensor, flexor, and lateral flexor groups in healthy normal subjects
      are useful for patient evaluation and for providing clinical training targets. To establish
      isometric endurance holding times, as well as ratios between torso extensors, flexors, and
      lateral flexors (stabilizers), for clinical assessment and rehabilitation targets. The tests
      proved reliable, with reliability coefficients of >.97 for the repeated tests on 5
      consecutive days and again 8 weeks later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Global Rating of Change Scale
time frame: 3 and 6 weeks and 3 months post discharge
description: Patients will rate their overall perception of improvement since beginning treatment on a scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7 large changes .
measure: Modified Oswestry Disability Index
time frame: Initial evaluation, 3 and 6 weeks and 3 months post discharge
description: The Modified ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score. Scores are associated with degree of disability ranging from minimal to bedbound. The ODI is a condition-specific disability scale for patients with LBP, consisting of 10 items addressing different aspects of function, each scored from 0-5 with higher values representing greater disability. This modified ODI has been found to have high levels of reliability, validity, and responsiveness . The MCID for the ODI has been identified at six points .On this scale, 0-20 equates to minimal disability, 20-40 moderate disability, 40-60 severe disability, 60-80 crippled, and 80-100 bed-bound or exaggerating.
measure: McGill's Physical Endurance Test Cluster
time frame: Initial evaluation, 3 weeks and 6 weeks
description: McGill has established a performance test to examine the endurance profiles of healthy young men and women for the spine stabilizing musculature . Given the growing support for quantification of endurance, these data of endurance times and their ratios between extensor, flexor, and lateral flexor groups in healthy normal subjects are useful for patient evaluation and for providing clinical training targets. To establish isometric endurance holding times, as well as ratios between torso extensors, flexors, and lateral flexors (stabilizers), for clinical assessment and rehabilitation targets. The tests proved reliable, with reliability coefficients of >.97 for the repeated tests on 5 consecutive days and again 8 weeks later.
arm group label: Motor Control
arm group type: Experimental
description: Pilates-based exercise with verbal cues to facilitate motor control Plank progression, use of feedback tool VERBAL CUES FOR MOTOR CONTROL GROUP (could also include above cues) "Maintain neutral spine" "Not too arched, not too flexed" "Remember your pilates position" "Inhale, exhale" "Let me hear your breath"
arm group label: General strengthening
arm group type: Active Comparator
description: Patient group that will receive active strengthening without specific verbal cueing to recruit deeper abdominal musculature. Core strengthening and lower quarter strengthening is the focus of this group.
Verbal cuing will include:
VERBAL CUEING FOR NON-MOTOR CONTROL GROUP
"Keep your back straight" "Don't slouch" "Don't arch your back" "Don't let your body move" "Nothing should move but your arms" "tighten up your abs" "suck in your stomach" "feet shoulder-width apart, knees bent, shoulders back, hold your stomach tight" Time will be kept the same as the intervention group.
intervention type: Other
intervention name: Motor Control
description: Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.
arm group label: Motor Control
intervention type: Other
intervention name: General Strengthening
description: General abdominal and lower quarter musculature strengthening
arm group label: General strengthening
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
last name: Megan B Donaldson, PT PhD
role: Principal Investigator
affiliation: Walsh University
facility: 
country: United States
citation: Dreisinger TE, Nelson B. Management of back pain in athletes. Sports Med. 1996 Apr;21(4):313-20. doi: 10.2165/00007256-199621040-00006.
PMID: 8726348
citation: Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.
PMID: 19352240
citation: Cavalier R, Herman MJ, Cheung EV, Pizzutillo PD. Spondylolysis and spondylolisthesis in children and adolescents: I. Diagnosis, natural history, and nonsurgical management. J Am Acad Orthop Surg. 2006 Jul;14(7):417-24. doi: 10.5435/00124635-200607000-00004.
PMID: 16822889
responsible party type: Sponsor-Investigator
investigator affiliation: Walsh University
investigator full name: Megan Donaldson PT, PhD, FAAOMPT
investigator title: Assistant Professor
mesh term: Spondylolisthesis
mesh term: Spondylolysis