Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Change in Cobb angle of at least 5 degrees
研究概览
简要总结
The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.
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
- 10 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 10 and 16 years old,
- •Cobb angle between 15º and 45º,
- •Risser sign ≤3 (skeletal growth incomplete),
- •with a risk of progression index > 1.3,
- •having recent x-rays (4-6 weeks),
- •ability to travel weekly to attend GPR intervention
排除标准
- •patients with diagnosis other than AIS,
- •patients who are planned for surgery,
- •have had surgery,
- •worn a brace for at least three months prior to GPR intervention
结局指标
主要结局
Change in Cobb angle of at least 5 degrees
时间窗: 6, 12 and 24 months
Angle measured on radiograph for scoliosis progression
次要结局
- Back pain on the Numerical Pain Rating Scale(6, 12 and 24 months)
- Italian Spine Youth Quality of Life questionnaire(6, 12 and 24 months)
- Trunk imbalance(6 and 12 months)
- Diaphragm excursion(6 and 12 months)
研究者
Carole Fortin
Associate professor
St. Justine's Hospital
