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临床试验/ChiCTR2500112330
ChiCTR2500112330已完成Unknown

A 24-Week Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention Versus Standard Care for Reducing Cobb Angle and Improving Paraspinal Muscle Function in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家开始时间: 2024年5月25日最近更新:

试验速览

阶段
Unknown
状态
已完成
试验地点
1
主要终点
Change in Major Cobb Angle

研究概览

简要总结

This study will investigate a 24-week Physiotherapy Scoliosis-Specific Exercise (PSSE) program for adolescents with idiopathic scoliosis, a condition that causes a curved spine and is often accompanied by imbalances in the paraspinal muscles (the muscles supporting the spine), including their activity and efficiency. While PSSE is a known treatment, its full effect on these underlying muscle problems is not yet fully understood. The main goal of this research is to test how effective the 24-week PSSE program is, compared to standard care alone, at improving the spinal curve (Cobb angle). We will also examine its impact on the paraspinal muscles, specifically how efficiently they use oxygen, their electrical activity measured by surface electromyography (sEMG), their stiffness, and the patient's overall quality of life.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
None

入排标准

年龄范围
10 至 16(—)
性别
All

入选标准

  • Adolescents aged 10 to 16 years.
  • Diagnosed with right-sided thoracic or thoracolumbar Adolescent Idiopathic Scoliosis (AIS), classified as Lenke types I, II, or III.
  • Have a primary Cobb angle between 10 and 45 degrees.
  • Show skeletal immaturity, indicated by a Risser sign of 0 to
  • Able to read and write in Chinese.
  • Participation is allowed regardless of whether they are currently using a spinal brace

排除标准

  • Diagnosis of a neuromuscular disease (e.g., cerebral palsy, muscular dystrophy) or a congenital spinal disorder.
  • A history of spinal surgery.
  • Have already completed a full course of brace treatment.
  • Any condition or situation that would make it difficult to follow the study procedures and protocol.

研究组 & 干预措施

PSSE intervention group

Control group

结局指标

主要结局

Change in Major Cobb Angle

时间窗: Baseline and 24 weeks

次要结局

  • Paraspinal Muscle Oxygen Recovery Time Asymmetry (TrAsy)(Baseline, 24 weeks, and 32 weeks)
  • Absolute Muscle Asymmetry Ratio (AMAR) of Muscle Stiffness(Baseline, 24 weeks, and 32 weeks)
  • Angle of Trunk Rotation (ATR)(Baseline, 24 weeks, and 32 weeks)
  • Scoliosis Research Society-22r (SRS-22r) Questionnaire Score(Baseline, 24 weeks, and 32 weeks)
  • Italian Spine Youth Quality of Life (ISYQOL) Questionnaire Score(Baseline, 24 weeks, and 32 weeks)
  • Spinal Appearance Questionnaire (SAQ) Score(Baseline, 24 weeks, and 32 weeks)
  • International Physical Activity Questionnaire-Short Form (IPAQ-C) Score(Baseline, 24 weeks, and 32 weeks)

研究者

发起方
未提供

研究点 (1)

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