An interventional study of Structured Physiotherapeutic Corrective Exercise Program and Standard Physiotherapy Exercise Program in Scoliosis Idiopathic Adolescent, sponsored by Alma Mater Europaea - Slovenia. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Alma Mater Europaea - Slovenia · Not applicable, Interventional, and Treatment
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.
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.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 68 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Alma Mater Europaea - Slovenia is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Structured Physiotherapeutic Corrective 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.
Behavioral: Standard Physiotherapy 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.
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.
Change in lateral spinal deviation
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 (°).
Time frame: Week 16
Change in vertebral rotation
Change from baseline to Week 16 in vertebral rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in trunk imbalance
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).
Time frame: Week 16
Change in trunk inclination
Change from baseline to Week 16 in trunk inclination measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in pelvic obliquity
Change from baseline to Week 16 in pelvic obliquity measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in pelvic torsion
Change from baseline to Week 16 in pelvic torsion measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in pelvic rotation
Change from baseline to Week 16 in pelvic rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in kyphotic angle
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 (°).
Time frame: Week 16
Change in lordotic angle
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 (°).
Time frame: Week 16
Change in spinal mobility
Change from baseline to Week 16 in spinal mobility measured using an inclinometer. The outcome will be reported in degrees (°).
Time frame: Week 16
Change in health-related quality of life
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.
Time frame: Week 16
Plan to share: No — 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.
Ran from Jan 2026 to primary completion in May 2026, 4 months.
Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's 4 months is below that.
Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.
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Alma Mater Europaea - Slovenia