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Effect of a 16-Week Physiotherapeutic Corrective Exercise Program on Spinal Deformities in Adolescent Idiopathic Scoliosis (SPINE-AIS16)

26 июля 2026 г. обновлено: Alma Mater Europaea - Slovenia

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

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.

Обзор исследования

Статус

Запись по приглашению

Условия

Вмешательство/лечение

Подробное описание

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.

Participants will be randomly allocated to an experimental or control group using stratified block randomization based on age and baseline Cobb angle. Outcome assessors and statisticians will be blinded to group allocation.

The experimental group will follow a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises commonly used in clinical practice for adolescent idiopathic scoliosis.

Both groups will receive supervised physiotherapy sessions three times per week for 16 weeks, each lasting approximately 45 minutes, and will perform additional home-based exercises two days per week.

Primary outcome measures will include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D Spine & Posture Analysis System, including change in lateral deviation angle and change in vertebral rotation. Each parameter will be analyzed as a separate outcome measure.

Secondary outcome measures will include individual postural and functional parameters assessed separately, including trunk imbalance, trunk inclination, pelvic obliquity, pelvic torsion, pelvic rotation, kyphotic angle, lordotic angle, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.

Measurements will be performed at baseline, 8 weeks, and 16 weeks. Statistical analysis will compare within-group and between-group changes over time using appropriate parametric and non-parametric tests, with statistical significance set at p < 0.05.

Additionally, agreement between angle of trunk rotation measured by scoliometer and vertebral rotation measured by the DIERS Formetric 3D/4D system will be evaluated as an exploratory analysis.

Тип исследования

Интервенционный

Регистрация (Оцененный)

68

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Косово
    • Kosovo
      • Pristina, Kosovo, Косово, 10000
        • Physical Medicine and Rehabilitation Clinic, University Clinical Center of Kosovo (UCCK)

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Structured Physiotherapeutic Corrective Exercise Program
Participants will receive a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises. Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
Поведенческий: Structured Physiotherapeutic Corrective Exercise Program
A 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises. Participants will attend supervised sessions three times per week and perform home exercises two additional days per week.
Активный компаратор: Standard Physiotherapy Exercise Program
Participants will receive a standard physiotherapy exercise program consisting of conventional strengthening, stretching, postural correction, and flexibility exercises. Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
Поведенческий: Standard Physiotherapy Exercise Program
The Standard Physiotherapy Exercise Program will last 16 weeks and consists of conventional therapeutic exercises aimed at improving spinal strength, flexibility, posture, and coordination in adolescents with idiopathic scoliosis.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in lateral spinal deviation
Временное ограничение: 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 (°).
Week 16
Change in vertebral rotation
Временное ограничение: 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 (°).
Week 16

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in trunk imbalance
Временное ограничение: Week 16
Change from baseline to Week 16 in trunk imbalance measured by the DIERS Formetric 3D/4D system. The outcome will be reported in millimeters (mm).
Week 16
Change in trunk inclination
Временное ограничение: Week 16
Change from baseline to Week 16 in trunk inclination measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in pelvic obliquity
Временное ограничение: Week 16
Change from baseline to Week 16 in pelvic obliquity measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in pelvic torsion
Временное ограничение: Week 16
Change from baseline to Week 16 in pelvic torsion measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in pelvic rotation
Временное ограничение: Week 16
Change from baseline to Week 16 in pelvic rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in kyphotic angle
Временное ограничение: Week 16
Change from baseline to Week 16 in thoracic kyphotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in lordotic angle
Временное ограничение: Week 16
Change from baseline to Week 16 in lumbar lordotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Week 16
Change in spinal mobility
Временное ограничение: Week 16
Change from baseline to Week 16 in spinal mobility measured using an inclinometer. The outcome will be reported in degrees (°).
Week 16
Change in health-related quality of life
Временное ограничение: Week 16
Change from baseline to Week 16 in health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire. Scores range from 22 to 110, with higher scores indicating better health-related quality of life.
Week 16

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Alma Mater Europaea - Slovenia

Соавторы

University Clinical Centre of Kosova
University of Pristina

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

12 января 2026 г.

Первичное завершение (Действительный)

12 мая 2026 г.

Завершение исследования (Оцененный)

12 августа 2026 г.

Даты регистрации исследования

Первый отправленный

16 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

26 июля 2026 г.

Первый опубликованный (Действительный)

30 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • UP-PT-2026-001 (Другой идентификатор: University of Prishtina - Faculty of Medicine)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations. The dataset contains sensitive clinical and anthropometric information of adolescent participants, and sharing of IPD is not planned to ensure compliance with institutional ethics approvals and data protection regulations. Aggregate results will be reported in publications and presentations.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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