Effect of Diaphragm Mobilization Added to the Schroth Best Practice Program in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Forced Vital Capacity
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known.
The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks.
Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.
详细描述
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine that occurs during growth and may affect posture, trunk mechanics, and respiratory function. Thoracic deformity and rib cage asymmetry associated with scoliosis can alter the biomechanical function of the diaphragm and reduce respiratory efficiency. Previous studies have reported decreased pulmonary function parameters in individuals with AIS, which may contribute to functional limitations and reduced quality of life.
Physiotherapeutic scoliosis-specific exercise approaches, such as the Schroth Best Practice (SBP) program, are widely used in the conservative management of scoliosis. The SBP program includes curve-specific corrective exercises and postural education aimed at improving spinal alignment, trunk symmetry, and functional capacity. Despite the documented benefits of SBP exercises, the potential role of diaphragm-focused manual therapy techniques in scoliosis rehabilitation has not been sufficiently investigated.
This study is designed as a prospective, randomized, parallel-group clinical trial to evaluate the effectiveness of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants diagnosed with AIS will be randomly assigned to one of two groups: (1) SBP exercise program combined with diaphragm mobilization or (2) SBP exercise program alone. The intervention will be performed three times per week for six weeks.
Clinical assessments will be conducted at baseline, at the end of the 6-week intervention period, and at a 12-week follow-up. Primary outcomes will include respiratory function parameters measured using spirometry, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and peak expiratory flow (PEF). Secondary outcomes will include trunk rotation measured using a scoliometer, thoracic mobility assessed by thoracic circumference difference during maximal inspiration and expiration, trunk lateral flexion flexibility, and patient-reported outcomes including quality of life (Scoliosis Research Society-22 questionnaire) and body image (Walter Reed Visual Assessment Scale).
The findings of this study are expected to provide evidence regarding the clinical effects of diaphragm mobilization when integrated into scoliosis-specific exercise programs and may contribute to the development of more comprehensive rehabilitation strategies for adolescents with 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)
盲法说明
Outcome assessments will be performed by a physiotherapist who is blinded to group allocation.
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 between 10 and 18 years
- •Diagnosis of adolescent idiopathic scoliosis
- •Cobb angle ≥ 10°
- •Ability to participate in exercise sessions
- •Written informed consent from the participant and their parent or legal guardian
排除标准
- •Non-idiopathic scoliosis (e.g., neuromuscular, congenital, or syndromic scoliosis)
- •Presence of congenital anomalies affecting the musculoskeletal system
- •Previous scoliosis treatment within the last 6 months
- •Participation in another physiotherapy or rehabilitation program during the study period
- •Current use of a scoliosis brace
- •History of spinal surgery
- •Presence of neurological, rheumatological, or cardiopulmonary diseases that may affect participation in the intervention
- •Cognitive impairment, communication disorders, or any condition that may limit the ability to follow instructions or complete assessments
研究组 & 干预措施
Schroth Best Practice Program + Diaphragm Mobilization
Participants in this group will receive the Schroth Best Practice exercise program combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks.
干预措施: Diaphragm Mobilization (Procedure)
Schroth Best Practice Program + Diaphragm Mobilization
Participants in this group will receive the Schroth Best Practice exercise program combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks.
干预措施: Schroth Best Practice Exercise Program (Behavioral)
Schroth Best Practice Program
Participants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks.
干预措施: Schroth Best Practice Exercise Program (Behavioral)
结局指标
主要结局
Forced Vital Capacity
时间窗: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Forced vital capacity (FVC), expressed in liters, will be measured by spirometry to assess pulmonary function.
Forced Expiratory Volume in One Second
时间窗: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Forced expiratory volume in one second (FEV1), expressed in liters, will be measured by spirometry to assess pulmonary function.
FEV1/FVC Ratio
时间窗: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
The FEV1/FVC ratio, expressed as a percentage, will be calculated from spirometry measurements to assess pulmonary function.
Peak Expiratory Flow
时间窗: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Peak expiratory flow (PEF), expressed in liters per minute, will be measured by spirometry to assess pulmonary function.
次要结局
- Trunk rotation angle measured by scoliometer(Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up))
- Thoracic mobility measured by thoracic circumference difference(Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up))
- Trunk lateral flexion flexibility(Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up))
- Quality of life measured by Scoliosis Research Society-22 questionnaire(Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up))
- Body image measured by Walter Reed Visual Assessment Scale(Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up))
研究者
Tuğba Kuru Çolak
Professor, Department of Physiotherapy and Rehabilitation
Marmara University