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临床试验/NCT07559539
NCT07559539招募中不适用

Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis With Comparison to Non-Operatively Treated and Non-Scoliotic Individuals

Józef Piłsudski University of Physical Education1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
ICF-Based Functional Limitations Questionnaire Total Score

研究概览

简要总结

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood.

This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires.

The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.

详细描述

Adolescent idiopathic scoliosis (AIS) is a structural spinal deformity associated with long-term alterations in musculoskeletal function, posture, and respiratory mechanics. In progressive cases, surgical correction using posterior spinal fusion (PSF) is performed during adolescence; however, long-term functional outcomes remain insufficiently characterized.

This observational, cross-sectional study compares adults with surgically treated AIS, conservatively treated AIS, and healthy controls. Participants will undergo a standardized assessment protocol including anthropometric measurements, clinical examination, and patient-reported outcomes.

Anthropometric assessment will include body height, sitting height, body mass, arm span, waist and hip circumference, lower limb length and asymmetry, and chest circumference at rest and maximal inspiration, with derived indices of body proportions.

Functional status will be assessed using an author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), capturing perceived limitations in body functions, activities, participation, and environmental factors.

Clinical evaluation will include assessment of spinal curvature and pelvic alignment using inclinometric and scoliometric methods, as well as range of motion (ROM) of the cervical spine, temporomandibular joint, and peripheral joints. Additional orthopedic functional tests will be performed to assess lumbopelvic and lower limb function.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female, age 25-40
  • •AIS diagnosed before age 18 (Cobb angle >35°)
  • •Operated group: PSF, 10-25 years post-surgery
  • •Informed consent

排除标准

  • •Surgery other than PSF
  • •Surgery performed in adulthood

结局指标

主要结局

ICF-Based Functional Limitations Questionnaire Total Score

时间窗: Baseline assessment, single study visit

Author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), assessing body functions, activities, participation, and environmental factors. Higher total scores indicate greater disability.

次要结局

  • SRS-22 Total Score(Baseline assessment, single study visit)
  • Lumbar Lordosis Angle(Baseline assessment, single study visit)
  • Pain Intensity by Visual Analog Scale (VAS)(Baseline assessment, single study visit)
  • Forced Vital Capacity (FVC % Predicted)(Baseline assessment, single study visit)
  • Forced Expiratory Volume in 1 Second (FEV1 % Predicted)(Baseline assessment, single study visit)
  • Angle of Trunk Rotation(Baseline assessment, single study visit)
  • Thoracic Kyphosis Angle(Baseline assessment, single study visit)

研究者

发起方
Józef Piłsudski University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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