The Effect of a 16-Week Structured Physiotherapeutic Corrective Exercise Program on Lateral Spinal Deviation, Vertebral Rotation, and Pelvic Position in Mild and Moderate Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in lateral spinal deviation
研究概览
简要总结
Brief Summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may progress during adolescence and lead to postural asymmetry, spinal rotation, pelvic imbalance, reduced spinal mobility, and decreased quality of life.
This randomized controlled trial aims to evaluate the effectiveness of a 16-week structured physiotherapeutic corrective exercise program compared with standard physiotherapy care in adolescents with mild to moderate AIS (Cobb angle 10°-40°).
Participants aged 10-18 years will be randomly assigned to either an experimental group or a control group using stratified block randomization based on age and baseline Cobb angle. The study will be conducted under the responsibility of the University of Prishtina- Faculty of Medicine and the University Clinical Center of Kosovo, with academic collaboration from Alma Mater Europaea.
The experimental group will receive a structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises used in routine clinical practice.
Both groups will undergo supervised physiotherapy sessions three times per week for 16 weeks, with additional prescribed home exercises.
Primary outcomes include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D system, including lateral deviation angle and vertebral rotation. Secondary outcomes include additional postural alignment parameters, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Assessments will be performed at baseline, 8 weeks, and 16 weeks. Each outcome parameter will be analyzed separately to evaluate changes over time and differences between groups.
The study will provide evidence on whether a structured corrective physiotherapy program offers superior outcomes compared with standard physiotherapy care in adolescents with AIS.
详细描述
Detailed Description
This randomized controlled trial evaluates the effectiveness of a structured physiotherapeutic corrective exercise program in adolescents with mild to moderate idiopathic scoliosis (Cobb angle 10°-40°), compared with standard physiotherapy care.
Adolescent idiopathic scoliosis is a structural spinal deformity characterized by lateral curvature, vertebral rotation, and postural imbalance. It may also be associated with pelvic asymmetry, altered sagittal spinal alignment, reduced spinal mobility, and impaired health-related quality of life.
Despite evidence supporting physiotherapeutic scoliosis-specific exercises, limited research has investigated comprehensive exercise programs addressing spinal alignment, postural control, and pelvic-related impairments simultaneously using advanced three-dimensional postural assessment systems.
Participants aged 10-18 years will be recruited from the Physical Medicine and Rehabilitation Clinic at the University Clinical Center of Kosovo and the University of Prishtina - Faculty of Medicine. The study is conducted under ethical approval from relevant institutional ethics committees. Alma Mater Europaea serves as an academic collaborating institution.
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)
盲法说明
Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
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
- 否
入选标准
- •Adolescents aged 10 to 18 years.
- •Diagnosis of mild to moderate adolescent idiopathic scoliosis (AIS) with a Cobb angle between 10° and 40°.
- •Referred for physiotherapy treatment at the Physical Medicine and Rehabilitation Clinic.
- •Ability to participate in a 16-week exercise program.
- •Written informed consent from a parent or legal guardian and assent from the participant.
- •Agreement not to receive additional scoliosis-specific treatment during the study period.
排除标准
- •Non-idiopathic scoliosis (congenital, neuromuscular, or syndromic scoliosis).
- •Cervicothoracic scoliosis.
- •Previous scoliosis surgery.
- •Brace treatment during the study period.
- •Previous scoliosis-specific physiotherapy during the study period.
- •Neurological disorders affecting posture or gait.
- •Congenital or structural spinal abnormalities.
- •Lower extremity neuromuscular disorders.
- •Leg length discrepancy.
- •Cardiovascular or respiratory conditions contraindicating exercise.
- •Inability to participate in the intervention or complete outcome assessments.
结局指标
主要结局
Change in lateral spinal deviation
时间窗: Week 16
Change from baseline to Week 16 in lateral spinal deviation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Change in vertebral rotation
时间窗: Week 16
Change from baseline to Week 16 in vertebral rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
次要结局
- Change in trunk imbalance(Week 16)
- Change in trunk inclination(Week 16)
- Change in pelvic obliquity(Week 16)
- Change in pelvic torsion(Week 16)
- Change in pelvic rotation(Week 16)
- Change in kyphotic angle(Week 16)
- Change in lordotic angle(Week 16)
- Change in spinal mobility(Week 16)
- Change in health-related quality of life(Week 16)