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临床试验/NCT06039657
NCT06039657已完成不适用

Effectiveness of Scientific Exercise Approach to Scoliosis in Adolescents With Mild Idiopathic Scoliosis

Hacettepe University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Cobb angle

研究概览

简要总结

İdiopathic scoliosis is a three dimensional deformity with lateral deviation and rotation of the spine. In idiopathic scoliosis, scoliosis-specific exercises are utilized as a primary treatment for moderate curves and as a supportive measure alongside bracing for more severe curves. SEAS, which stands for Scientific Exercises Approach to Scoliosis, refers to a treatment approach developed as a scientific exercise methodology for scoliosis. This approach aims to provide scoliosis-specific exercises and techniques to manage and potentially improve the condition. This study aims to investigate the effectiveness of SEAS as a conservative treatment approach for mild AIS.

详细描述

Adolescent idiopathic scoliosis (AIS) constitutes a multifaceted distortion involving three-dimensional structural curvature of the spine, accompanied by biomechanical alterations that advance gradually, exerting an adverse influence on the quality of life related to health in individuals ranging from 10 to 18 years of age. In idiopathic scoliosis, curvatures ranging from 10 to 25 degrees are categorized as mild, while curvatures between 25 and 45 degrees are considered moderate, and those exceeding 45 degrees are classified as severe. For mild scoliosis, scoliosis specific exercises are the main treatment method. SEAS (Scientific Exercises Approach to Scoliosis), a specific type of scoliosis specific exercise program, focuses on using scientific principles to address the unique needs of individuals with scoliosis. It aims to improve posture, spinal alignment, and muscle balance through tailored exercises. SEAS exercises involve three-dimensional spinal correction and are designed to enhance neuromuscular control and proprioception in this corrective position. The available research regarding SEAS in adolescent idiopathic scoliosis (AIS) is somewhat limited both in terms of quantity and scope, underscoring the necessity for more comprehensive investigations. Drawing from the existing literature landscape and the identified gaps, our hypothesis centers on the notion that the incorporation of SEAS is poised to yield noteworthy enhancements across various dimensions of AIS. Consequently, the primary objective of this study was to assess the efficacy of SEAS training in ameliorating parameters such as Cobb angle, axial trunk rotation, bodily aesthetics, and health-related quality of life in individuals diagnosed with mild AIS. Patients in this study were treated using two different protocols based on a shared decision-making model. Patients and their families were informed about the pathology, history and progression risk of idiopathic scoliosis, as well as the exercise options and expected outcomes. Consequently, every patient along with their parents comprehensively grasped the significance of scoliosis-specific exercises in proactively rectifying and maintaining their spinal alignment throughout diverse functional activities. Patients who choose for exercise treatment underwent SEAS therapy, while those who declined or were unable to participate in outpatient exercise programs received standard care.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • Patients with Adolescent Idiopathic Scoliosis (AIS).
  • A Cobb angle measurement falling within the range of 12° to 25°.
  • Patients considered for the study were required to be within the age range of 10 to 16 years old.
  • have a Risser score ranging from 0 to 4.

排除标准

  • Patients with a history of prior spine treatment, including surgery or conservative treatment
  • Patients with a history of traumatic spinal injury
  • Individuals with rheumatologic disorders, which affect the joints and connective tissues
  • Patients with systemic disorders, which affect multiple organ systems in the body
  • Those with neurologic disorders, impacting the nervous system
  • Individuals with any other musculoskeletal disorders

结局指标

主要结局

Cobb angle

时间窗: Measurements were performed at baseline and at the end of the one-year treatment period.

The Cobb angle was used to quantify the degree of spinal curvature in scoliosis, determined by the angle formed by lines drawn along the endplates of the vertebrae at the curve's apex and endpoints

次要结局

  • Axial trunk rotation(Measurements were performed at baseline and at the end of the one-year treatment period.)
  • Spinal Appearance Questionnaire (SAQ)(Measurements were performed at baseline and at the end of the one-year treatment period.)
  • Scoliosis Research Questionnaire-22 (SRS-22)(Measurements were performed at baseline and at the end of the one-year treatment period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Yagci (Gür)

Assoc. Prof

Hacettepe University

研究点 (2)

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