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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

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DataONE2017-05-29 更新2024-06-26 收录
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This multicentre study will be a two parallel arms assessor- and statistician-blinded randomized controlled trial comparing a six-months Schroth exercise intervention added to standard of care (experimental group) to standard of care alone (control group). Combined with standard care, the Schroth intervention group will receive five individual training sessions, followed by weekly group classes and daily home exercises for 6 months. After the first six months, the experimental group will be advised to continue the unsupervised home programme until the discharge from the scoliosis clinic, while the control group will be offered the Schroth treatment for six months. The primary aim 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: 1. 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. 2. 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) and 3. 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 effect of Global Postural Re-education will also be examined because Global Postural Re-education exercises were offered routinely to patients at that institution prior to the trial.

本项多中心研究为双臂平行设计、评估者与统计师双盲的随机对照试验,旨在对比联合标准护理的施罗斯(Schroth)运动干预方案(实验组)与单纯标准护理方案(对照组)的疗效差异。实验组在接受标准护理的基础上,将先完成5次个体化训练课程,随后接受为期6个月的每周集体课程与每日居家训练。在前6个月干预周期结束后,实验组将被建议继续开展无监督居家训练方案,直至从脊柱侧弯门诊出院;而对照组则可获得为期6个月的施罗斯治疗。本研究的主要研究目标为:对比“6个月施罗斯运动方案联合标准护理”与“单纯标准护理”对脊柱侧弯弯曲严重程度(通过Cobb角量化评估)的影响。次要研究目标包括:1. 评估干预6个月时施罗斯运动对次要结局指标的影响,次要结局涵盖生存质量、脊柱外观、客观体态与脊柱肌肉耐力水平;2. 评估在完成6个月标准护理后转为接受6个月施罗斯治疗的对照组受试者的疗效(以受试者自身作为自身对照);3. 探究6个月监督式施罗斯运动方案的疗效在监督治疗终止后是否可得到维持。此外,在圣朱斯蒂医院(Hopital Ste-Justine),本研究还将评估全球体态再训练(Global Postural Re-education)的疗效,因该机构在试验开展前常规为患者提供全球体态再训练课程。

创建时间:
2023-12-28
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