Scoliosis-Specific Exercises for At-Risk Mild Adolescent Idiopathic Scoliosis Curves: A Multi-Site Preliminary Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Overall Recruitment Rate
研究概览
简要总结
This study will be a multi-center, dual-arm randomized control study evaluating skeletally immature patients with mild AIS curves. At six institutions, patients will be randomized into either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group will receive training in SSE, posture, and activities of daily living by physical therapists certified in Schroth-based exercise methods. The control group will not receive SSE instruction and will only be observed by their treating orthopaedic surgeon (which is considered the standard-of-care treatment method). Results will be compared after one year of treatment.
详细描述
All patients with AIS meeting the following inclusion criteria will be eligible to participate in this trial: diagnosis of AIS; ages 10 to 17 years; major curve Cobb angles 15° to 20°; thoracolumbar, lumbar, or primary thoracic curve patterns; and Risser grade 0. Curves less than 15° will not be as clinically meaningful if they do not progress more than 5°. Curves 15° also allow for 5° of measurement error. Curves more than 20° will not be able to progress at least 5° before bracing is initiated according to SRS criteria (at 25°). Patients will be excluded according to the following exclusion criteria: scoliosis other than AIS, upper thoracic or double curve patterns, developmental disorders that prevent understanding and compliance with an exercise schedule, current or previous brace wear, and previous participation in a SSE program, previous spine surgery, inability to commit to performing a home exercise program for 15 minutes a day, 5 days a week, and inability to commit to attend at least 8 hours of PT within 6 months.
Patient medical records will be reviewed for eligibility. If a patient is deemed eligible for inclusion in the study, a member of the research team will meet with the patient and his or her family to review the consent form in a private medical exam room. The family will be given ample time to review the consent form and ask any questions. If a participant chooses to participate, a consent form will be signed by both the patient and the legal guardian prior to any investigational procedures occurring. Once a consent form has been signed, patients will be randomly assigned by the TSRH on site statistician to one of the two following groups:
- Standardization of Physical Therapy:
Physical therapists from Texas Scottish Rite Hospital, Boston Children's Hospital, Columbia University Medical Center, Norton Leatherman Spine Center, Johns Hopkins University, and Texas Children's Hospital who received training and certification in the Schroth-based (BSPTS) method have been recruited as members of the study team. Physical therapists at each institution will deliver a standardized exercise intervention. 2. Study Groups:
A) Scoliosis-Specific Exercise (SSE) Group
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
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with Adolescent Idiopathic Scoliosis who meet the following inclusion criteria will be eligible to participate in this trial:
- •Age 10 to 17 years
- •Major curve Cobb angles of 12° to 24°
- •Risser Grade 0
- •Single thoracic, thoracolumbar, or lumbar curve patterns
排除标准
- •Patients will be excluded according to the following exclusion criteria:
- •Scoliosis other than AIS (congenital, neuromuscular, etc)
- •Upper thoracic or double curve patterns
- •Diagnosis of a developmental disorder that prevents understanding and compliance with an exercise schedule
- •Current or previous brace wear
- •Previous participation in a SSE program
- •Previous spine surgery
- •Patient inability to commit to attend at least 8 hours of PT within 6 months
研究组 & 干预措施
Physical Therapy Exercise Group
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions.
Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
干预措施: Scoliosis Specific Exercises (Behavioral)
Control Group
Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.
结局指标
主要结局
Overall Recruitment Rate
时间窗: through study completion up to 45 months
Measured by the number of participants enrolled through study completion.
Treatment Attendance in the SSE Group
时间窗: after 1 year
Measured by the number of prescribed hours of physical therapy sessions attended after 1 year
Home Exercise Adherence in the SSE Group According to Weekly E-mails
时间窗: 1 year
Measured by the percentage of prescribed exercises completed from baseline to 1 year
次要结局
- Curve Magnitude(1 year)
- Curve Progression(after 1 year)
- Brace Prescription(after 1 year)
研究者
Karina Zapata, PT, DPT, PhD
Principal Investigator
Texas Scottish Rite Hospital for Children