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临床试验/NCT05259956
NCT05259956已完成不适用

The Impact of "3+1" Multidimensional Therapeutic Exercises on the Progression of Adolescent Idiopathic Scoliosis

Peking University Aerospace Centre Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Change From Baseline in Ratio of Iliac Widths at 24th week

研究概览

简要总结

Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.

详细描述

Adolescent idiopathic scoliosis is the most common three-dimensional structural deformity of the spine among adolescence, the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment recommend specific exercise therapy to delay the progression of scoliosis. Many specific exercise therapies are effective in reducing the angle of coronal scoliosis, but their efficiency in sagittal and axial deformities hasn't been convincing. Recent studies have found that the axial asymmetry of the pelvis may be involved in the pathogenesis of idiopathic scoliosis, but there is no clinical study on the treatment of scoliosis by correcting the axial torsion of the pelvis neither at home nor abroad. So in this study, "3 plus 1" multidimensional exercise therapy was applied to mild adolescent idiopathic scoliosis for the first time.

The present study is a single-center randomized controlled trial conducted at the department of rehabilitation medicine, Aerospace Center Hospital. The written Informed consent will be obtained from each patient and one of their parents before inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio either to the experimental group, in which the "3 plus 1" multidimensional exercise therapy will be performed and pelvic correction technique was adopted to correct pelvic axial rotation, or the control group, in which they will receive the Schroth-based exercise therapy. Blinded assessments will be conducted at baseline and 6-month after the intervention, including the differences in three-dimensional structural parameters of pelvis and spine, such as the ratio of the iliac widths, SRS-22 questionnaire, etc, to compare the efficacy of two different groups in improving the three-dimensional balance of the spine and the quality of daily life in adolescent idiopathic scoliosis.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).

排除标准

  • Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.

结局指标

主要结局

Change From Baseline in Ratio of Iliac Widths at 24th week

时间窗: baseline and at 24th week

Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.

次要结局

  • Change in Apical Vertebral Translation in Main Curves(baseline and at 24th week)
  • Change in Cobb Angle(baseline and at 24th week)
  • Change in Coronal Pelvic Tilt(baseline and at 24th week)
  • Change in Apical Vertebral Rotation in Main curves(baseline and at 24th week)
  • Change in Scoliosis Research Society-22 Questionnaire(baseline and at 24th week)
  • Change in Angle of Trunk Rotation(baseline and at 24th week)

研究者

发起方
Peking University Aerospace Centre Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Yafei

Principal Investigator

Peking University Aerospace Centre Hospital

研究点 (1)

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