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Trial record 11 of 38 for:    "Spinal Disease" | "Benzocaine"

The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01711203
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : January 21, 2015
Akron Children's Hospital
Information provided by (Responsible Party):
Megan Donaldson PT, PhD, FAAOMPT, Walsh University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Spondylolisthesis Spondylolysis Children Other: Motor Control Other: General Strengthening Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Motor Control
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"
Other: Motor Control
Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.

Active Comparator: General strengthening

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:


"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.

Other: General Strengthening
General abdominal and lower quarter musculature strengthening

Primary Outcome Measures :
  1. Global Rating of Change Scale [ Time Frame: 3 and 6 weeks and 3 months post discharge ]
    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 .

Secondary Outcome Measures :
  1. Modified Oswestry Disability Index [ Time Frame: Initial evaluation, 3 and 6 weeks and 3 months post discharge ]
    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.

Other Outcome Measures:
  1. McGill's Physical Endurance Test Cluster [ Time Frame: Initial evaluation, 3 weeks and 6 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age of subject must be between 8-21 years old
  2. Ability to read and understand the English language
  3. Parent/caregiver attendance and consent for initial evaluation
  4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician with or without imaging

Exclusion Criteria:

  1. Not meeting the inclusion criteria
  2. Not able to attend therapy 2x's per week
  3. If physician prescription requests only physical bracing as rendered treatment
  4. If patient presents with signs of neurological compromise
  5. Red flags during the medical screening that would require the patient to see the physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01711203

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United States, Ohio
Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Megan Donaldson PT, PhD, FAAOMPT
Akron Children's Hospital
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Principal Investigator: Megan B Donaldson, PT PhD Walsh University

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Responsible Party: Megan Donaldson PT, PhD, FAAOMPT, Assistant Professor, Walsh University Identifier: NCT01711203     History of Changes
Other Study ID Numbers: Spondy 12-35
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Megan Donaldson PT, PhD, FAAOMPT, Walsh University:
Physical Therapy
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases