A Multicenter Randomized Controlled Trial to Compare the Effect of Schroth Exercises to Standard Care on Curve Characteristics, Posture, and Quality Of Life in Adolescents With Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 6
- 主要终点
- Change in Cobb angle
研究概览
简要总结
The primary aim of this multicenter randomized controlled trial is to compare the effect of a 6 month "Schroth exercise program combined with standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the Cobb angle.
Secondary aims include:
- To determine the effect of Schroth exercises at 6 months on secondary outcomes including quality-of-life, spinal appearance, objective posture and spinal muscle endurance measurements.
- To determine the efficacy of 6 months of Schroth therapy offered to control participants after completing 6 months in the standard-of care group (using subjects as their own controls)
- To determine if the effects of the 6 months supervised Schroth exercise program can be maintained after supervised therapy is terminated.
At Hopital Ste-Justine, the following secondary aims will be pursued to examine the preliminary evidence about the effect of Global Postural Re-education (to satisfy the local ethics committee request because Global Postural Re-education exercises were offered routinely to patients at that institution prior to the trial).
A. To compare the effect and to quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care consisting of only observation and bracing" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on scoliosis curve severity measured using the Cobb angle.
B. To estimate the effect and quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal muscle endurance measurements.
C. To determine if the effects of "Global Postural Re-education exercises with North American standard Care" can be maintained after discontinuing supervision.
D. To estimate the feasibility of conducting a randomized trial focused on Global Postural Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise sessions and compliance with the home exercises prescribed.
详细描述
Multicenter Schroth Exercise Trial for Scoliosis (SETS study) Adolescent Idiopathic Scoliosis (AIS) is a progressive 3D deformity of the spine. It is the most common orthopedic condition in adolescents. Of those with curves larger than 10°, 90% are females. Scoliosis often results in chronic pain, poor posture, function, and self-image.
Curves greater than 30° are braced or later surgically corrected. In Europe but not the Americas, small curves (<30°) are treated with exercises to prevent the need for bracing and moderate curves with bracing and exercises to prevent surgery. Bracing is uncomfortable and patients fear surgery. In contrast, exercises are generally well received.
Schroth exercises are the most studied scoliosis exercises and have achieved very good outcomes. Schroth was the first exercise approach to offer formal certification training. No randomized controlled trial has focused on the Schroth method. Only 1 randomized controlled trial and only 3 prospective controlled studies with important methodological flaws were included in a recent review of the effect of all types of scoliosis exercises that found that exercises slowed the worsening of scoliosis. A randomized controlled trial on Schroth exercises is needed.
Schroth exercises are asymmetric scoliosis-specific postural exercises and aim to improve the curve, posture, pain, function, and self-image. Schroth exercises target endurance and strength training of the abdominal, back, and leg muscles. Schroth exercises also aim to improve motor control of the posture by repeating corrective movements with progressively less feedback.
Objectives: (1) To compare the effect of 6 month "of Schroth exercises combined with standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the Cobb angle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adolescent idiopathic scoliosis
- •10° to 45° according to Cobb (scoliosis curve)
- •with or without a brace
- •ability to travel weekly to our lab
- •skeletal maturity measured by Risser (0-3)
排除标准
- •other type of scoliosis
- •patients with curves > 50°
- •surgical candidates
- •patients who have had a corrective spinal surgery
- •out-of town candidates, without possibility to travel to our lab
结局指标
主要结局
Change in Cobb angle
时间窗: From baseline to 6 months
The angle from a posterior anterior full spine radiographs between the upper endplate of the upper end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
次要结局
- Change in numeric pain ratings and diagram(From baseline, to 3 and to 6 months)
- Change in Spinal Appearance Questionnaire scores(From baseline, to 3, and to 6 months)
- Global rating of change relative to baseline(at 3 and at 6 months)
- Change in Vertebral rotation(Change from baseline to 6 months)
- Change in Scoliosis Research Society-22r questionnaire scores(From baseline, to 3 months and to 6 months follow-ups)
- Change in Self-efficacy(From baseline, to 3 and to 6 months)
- Change in surface topography assessment of posture(From baseline, to 3 and to 6 months)
- Change in Back muscle endurance(From baseline, to 3 months and to 6 months follow-ups)