Children Clinical Trial
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
Verified date | January 2015 |
Source | Walsh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 21 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center | Akron | Ohio |
Lead Sponsor | Collaborator |
---|---|
Megan Donaldson PT, PhD, FAAOMPT | Akron Children's Hospital |
United States,
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. Review. — View Citation
Dreisinger TE, Nelson B. Management of back pain in athletes. Sports Med. 1996 Apr;21(4):313-20. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | McGill's Physical Endurance Test Cluster | 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. | Initial evaluation, 3 weeks and 6 weeks | No |
Primary | Global Rating of Change Scale | 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 . | 3 and 6 weeks and 3 months post discharge | No |
Secondary | Modified Oswestry Disability Index | 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. | Initial evaluation, 3 and 6 weeks and 3 months post discharge | No |
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