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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Walsh University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Akron Children's Hospital
Information provided by (Responsible Party):
Megan Donaldson PT, PhD, FAAOMPT, Walsh University
ClinicalTrials.gov Identifier:
NCT01711203
First received: October 9, 2012
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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 Intervention
Spondylolisthesis
Spondylolysis
Children
Other: Motor Control
Other: General Strengthening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Walsh University:

Primary Outcome Measures:
  • Global Rating of Change Scale [ Time Frame: 3 and 6 weeks and 3 months post discharge ] [ Designated as safety issue: No ]
    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:
  • Modified Oswestry Disability Index [ Time Frame: Initial evaluation, 3 and 6 weeks and 3 months post discharge ] [ Designated as safety issue: No ]
    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:
  • McGill's Physical Endurance Test Cluster [ Time Frame: Initial evaluation, 3 weeks and 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

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.

Other: General Strengthening
General abdominal and lower quarter musculature strengthening

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of subject must be between 12-21 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711203

Contacts
Contact: Malinda Bragg, MS PT 330-543-2113 mbragg@chmca.org
Contact: Cortney Myer, DPT 330-543-2115 cmyer@chmca.org

Locations
United States, Ohio
Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center Recruiting
Akron, Ohio, United States, 44308
Contact: Mindy Bragg, MS PT    330-543-2113    mbragg@chmca.org   
Principal Investigator: Mindy Bragg, MS PT         
Sub-Investigator: Cortney Myer, DPT         
Sub-Investigator: Lori Ross, PT         
Sponsors and Collaborators
Megan Donaldson PT, PhD, FAAOMPT
Akron Children's Hospital
Investigators
Principal Investigator: Megan B Donaldson, PT PhD Walsh University
  More Information

Publications:
Responsible Party: Megan Donaldson PT, PhD, FAAOMPT, Assistant Professor, Walsh University
ClinicalTrials.gov Identifier: NCT01711203     History of Changes
Other Study ID Numbers: Spondy 12-35
Study First Received: October 9, 2012
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Walsh University:
Spondylolysis
Spondylolisthesis
Rehabilitation
Physical Therapy
Children

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014