The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
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|ClinicalTrials.gov Identifier: NCT01711203|
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : January 21, 2015
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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 .
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01711203
|United States, Ohio|
|Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center|
|Akron, Ohio, United States, 44308|
|Principal Investigator:||Megan B Donaldson, PT PhD||Walsh University|