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

26 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

68

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in lateral spinal deviation
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in trunk imbalance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alma Mater Europaea - Slovenia

Współpracownicy

University Clinical Centre of Kosova
University of Pristina

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 stycznia 2026

Zakończenie podstawowe (Rzeczywisty)

12 maja 2026

Ukończenie studiów (Szacowany)

12 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

16 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 lipca 2026

Pierwszy wysłany (Rzeczywisty)

30 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • UP-PT-2026-001 (Inny identyfikator: University of Prishtina - Faculty of Medicine)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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