Pilot Study for a Randomized Controlled Clinical Trial on the Effect of Global Postural Re-education in the Treatment of Idiopathic Scoliosis: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Cobb angle
研究概览
简要总结
In North America, children and adolescents with idiopathic scoliosis (IS) are rarely referred for a rehabilitation program whereas the European guidelines stated that scientific evidences concerning scoliosis specific physiotherapy exercises were strong enough to recommend the use of these exercises at an early stage. The objectives of this pilot study is to assess feasibility of conducting a larger randomized control trial (RCT) on the effect of global postural re-education (GPR) on scoliosis progression (Cobb angle) and posture, back pain and participation and to assess the equivalence of two groups of GPR interventions. A convenience sample of 60 adolescents with IS (Cobb angle 15º-50º, Risser sign ≤3) will be recruited at CHU Sainte-Justine. Participants will be randomly allocated to GPR-A (individual sessions once a week) or GPR-B (individual sessions once per two weeks alternately with class exercises once per two weeks) for 6 months. After 6 months, groups will be interchanged for another 6 months. Feasibility outcomes will be recruitment rate, consent rate, completion rate and adherence to treatment at 12 months. The primary outcome of the effect of GPR will be the Cobb angle. Secondary outcomes will be: posture, back pain and participation at 6 and 12 months. Statistical analyses: For feasibility, percentage of eligible patients recruited, percentage of recruited patients who completed the trial and adherence to treatment will be calculated. For the preliminary effects of GPR, linear mixed-models will be used to assess differences in groups' changes from baseline, to 6 and 12-month while adjusting for covariates (age, Risser, adherence). Separate analyses will be conducted for each outcome.
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)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 8 and 16 years old,
- •Cobb angle between 15º and 50º,
- •a Risser sign ≤3 (skeletal growth incomplete),
- •having recent x-rays (4-6 weeks),
- •ability to travel weekly to attend GPR interventions
排除标准
- •patients who are planning surgery or have had surgery,
- •previous regular physiotherapy or other conservative treatment (chiro, osteopathy),
- •worn a brace for at least three months prior to GPR interventions,
- •scheduled for clinic follow-up later than in 6±2 months,
- •or to be discharged before 12 months.
研究组 & 干预措施
GPR-A
The 6-months supervised GPR-A group will receive a 1-hour-long individual session once a week plus a home program (1 or 2 exercises, 2 times a week).
干预措施: GPR-A (Other)
GPR-B
The 6-months supervised GPR-B group will receive a 1-hour long individual session once per two weeks alternately with a 1-hour-long class of exercises once per two weeks plus a home program (1 or 2 exercises, 2 times a week).
干预措施: GPR-B (Other)
结局指标
主要结局
Change in Cobb angle
时间窗: 6 and 12 months
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
次要结局
- Posture: shoulder elevation(6 and 12 months)
- Posture: right waist angle(6 and 12 months)
- Posture: left waist angle(6 and 12 months)
- Posture: thoracic scoliosis(6 and 12 months)
- Posture: lumbar scoliosis(6 and 12 months)
- Posture: frontal trunk list(6 and 12 months)
- Posture: frontal pelvic tilt(6 and 12 months)
- Posture: right sagittal pelvic tilt(6 and 12 months)
- Posture: left sagittal pelvic tilt(6 and 12 months)
- Posture: scapula asymmetry(6 and 12 months)
- Change in back pain(6 and 12 months)
- Change in score of The youth version of the Child & Adolescent Scale of Participation(12 months)
研究者
Carole Fortin
Professor
St. Justine's Hospital