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Набор скоро начнётся NCT07482748

Diaphragm Mobilization in Adolescent Idiopathic Scoliosis

Без фазы С лечением Adolescent Idiopathic Scoliosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diaphragm Mobilization, Schroth Best Practice Exercise Program.
Кому может быть актуально
Состояния в реестре: Adolescent Idiopathic Scoliosis. Базовые параметры: 10 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Diaphragm Mobilization Added to the Schroth Best Practice Program in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Diaphragm Mobilization
    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 betwe
  • Поведенческое Schroth Best Practice Exercise Program
    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.

Первичные конечные точки

  • Forced Vital Capacity [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Forced Expiratory Volume in One Second [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • FEV1/FVC Ratio [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Peak Expiratory Flow [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
Вторичные конечные точки (5)
  • Trunk rotation angle measured by scoliometer [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Thoracic mobility measured by thoracic circumference difference [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Trunk lateral flexion flexibility [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Quality of life measured by Scoliosis Research Society-22 questionnaire [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]
  • Body image measured by Walter Reed Visual Assessment Scale [Срок оценки: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07482748 · 09.2025/303

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗