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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Global Rating of Change Scale
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of subject must be between 8-21 years old
- •Ability to read and understand the English language
- •Parent/caregiver attendance and consent for initial evaluation
- •Written medical diagnosis of spondylolysis or spondylolithesis from the physician with or without imaging
排除标准
- •Not meeting the inclusion criteria
- •Not able to attend therapy 2x's per week
- •If physician prescription requests only physical bracing as rendered treatment
- •If patient presents with signs of neurological compromise
- •Red flags during the medical screening that would require the patient to see the physician
结局指标
主要结局
Global Rating of Change Scale
时间窗: 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 .
次要结局
- Modified Oswestry Disability Index(Initial evaluation, 3 and 6 weeks and 3 months post discharge)
研究者
Megan Donaldson PT, PhD, FAAOMPT
Assistant Professor
Walsh University