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青少年特发性脊柱侧凸中的膈肌松动术

2026年11月5日 更新者:Tuğba Kuru Çolak、Marmara University

膈肌松动术结合Schroth最佳实践方案对青少年特发性脊柱侧凸的影响:一项随机对照试验

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Istanbul、土耳其(türkiye)
        • Marmara Üniversitesi, Sağlık Bilimleri Fakültesi, Fizyoterapi ve Rehabilitasyon Bölümü

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

Manual diaphragm mobilization will be performed with the participant in the supine position. The therapist will place both hands along the inferior costal margin and apply a gentle mobilization in coordination with the participant's breathing cycle. During inspiration and expiration, the inferior costal margin will be mobilized in a cranial and lateral direction. The technique will be performed for 20 breathing cycles and repeated twice during each treatment session with short rest periods between repetitions. The intervention will be applied at the end of each treatment session throughout the 6-week treatment period.

其他名称:
  • 手动膈肌松解
  • 膈肌松动术

The Schroth Best Practice (SBP) program is a physiotherapeutic scoliosis-specific exercise approach that includes curve-specific corrective exercises and postural education. Participants will perform exercises tailored to their scoliosis curve pattern under the supervision of a physiotherapist. The program will be applied three times per week for six weeks.

其他名称:
  • 施罗特体操
有源比较器:Schroth Best Practice Program

Participants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks.

The Schroth Best Practice (SBP) program is a physiotherapeutic scoliosis-specific exercise approach that includes curve-specific corrective exercises and postural education. Participants will perform exercises tailored to their scoliosis curve pattern under the supervision of a physiotherapist. The program will be applied three times per week for six weeks.

其他名称:
  • 施罗特体操

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Forced Vital Capacity
大体时间: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.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Forced Expiratory Volume in One Second
大体时间: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.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
FEV1/FVC Ratio
大体时间: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.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Peak Expiratory Flow
大体时间: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.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

次要结果测量

结果测量
措施说明
大体时间
Trunk rotation angle measured by scoliometer
大体时间:Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Angle of trunk rotation will be measured using a scoliometer during the forward Adam's bending test to assess spinal rotation.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Thoracic mobility measured by thoracic circumference difference
大体时间:Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Thoracic mobility will be assessed by measuring chest circumference at the xiphoid process level during maximal inspiration and maximal expiration using a measuring tape. The difference between the two measurements will be recorded in centimeters.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Trunk lateral flexion flexibility
大体时间:Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Trunk lateral flexion flexibility will be assessed by measuring the distance between the fingertips and the floor during lateral bending. Measurements will be performed bilaterally, and the distance between the fingertips and the floor will be recorded in centimeters.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Quality of life measured by Scoliosis Research Society-22 questionnaire
大体时间:Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire. This questionnaire assesses multiple domains including function/activity, pain, self-image, mental health, and satisfaction with management. The total score ranges from 22 to 110, higher scores indicate better health-related quality of life.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Body image measured by Walter Reed Visual Assessment Scale
大体时间:Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Body image perception will be assessed using the Walter Reed Visual Assessment Scale (WRVAS). The WRVAS evaluates the patient's perception of scoliosis-related trunk deformity using visual illustrations. Total scores range from 7 to 35, with higher scores indicating greater perceived deformity and worse body image perception.

Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tuğba KURU ÇOLAK, PT, PhD、Marmara University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月20日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年3月6日

首先提交符合 QC 标准的

2026年3月16日

首次发布 (实际的)

2026年3月19日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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