Pre-operative Flexibility Exercises for Surgery for Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of levels fused
研究概览
简要总结
The goal of this clinical trial is to determine if pre-operative scoliosis-specific exercises have a beneficial effect on the health outcomes of surgery for adolescent idiopathic scoliosis. Adolescent idiopathic scoliosis affects adolescents between the age of 10-18.
The main questions this study aims to answer are:
- Can pre-operative exercises help reduce curve progression prior to surgery?
- Can pre-operative exercises help improve the surgery outcomes, such as a lower number of vertebrae needing fusion, increased curve correction, reduced surgery length, and shorter length of stay in the hospital?
- Can a pre-operative exercise intervention result in a reduction of the cost of surgery?
Researchers will compare the current standard of care (the control group) to an intervention group (with pre-op exercises) to see if pre-op exercises have an effect on these outcomes.
Participants will:
- visit the clinic every 3 months to complete ultrasound imaging scans and questionnaires
- if given an exercise intervention, aim to complete it for roughly 30 minutes a day
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
- Single (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of adolescent idiopathic scoliosis
- •aged 10 to 18
- •curve angle >40 degrees
- •waitlisted for posterior spinal fusion surgery at the Stollery Hospital
排除标准
- •previous surgeries
- •current use of scoliosis-specific exercises
研究组 & 干预措施
Standard of Care (Control)
The Standard of Care (Control) Group is the group that will receive the current standard of care offered in the process of treating AIS with surgery.
Pre-op Exercise Intervention
The Pre-op Exercise Intervention Group will receive the current standard of care offered when treating AIS with surgery, and will also be offered the intervention by the research team that is a pre-op exercise program aimed to increase flexibility of the spine and reduce scoliosis progression.
干预措施: Pre-op Exercise Program (Behavioral)
结局指标
主要结局
Number of levels fused
时间窗: Indicated during surgical planning, completed during surgery (where it may change from plans)
The number of vertebrae levels fused during surgery for AIS. This is an indicator of the amount of flexibility afforded to participants post-op, their risk of adverse wear and tear on unoperated levels, and also can indicate significant cost savings to the hospital and health system.
次要结局
- Italian Spine Youth Quality of Life (ISYQOL) questionnaire(Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op))
- Spinal Appearance Questionnaire (SAQ) v1.1 Appearance score(Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op))
- Spinal Appearance Questionnaire (SAQ) v1.1 expectation score(Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op))
- Spinal Appearance Questionnaire (SAQ) v1.1 total score(Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op))
- Pre-operative flexibility measured by 3D Ultrasound Imaging(Baseline, 3 months, and 6 months)
- Other Surgery-related Outcomes(During surgery & immediately post-surgery)
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Appearance(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast Location(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast shape(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast size(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing General(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
- Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing Specific(Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op))
研究者
Eric Parent
Professor
University of Alberta