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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Scoliosis Idiopathic Adolescent
• Intervention / Treatment: Behavioral: Structured Physiotherapeutic Corrective Exercise Program; Behavioral: Standard Physiotherapy Exercise Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (°).	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 (°).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 (°).	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 (°).	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 (°).	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 (°).	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 (°).	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 (°).	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 (°).	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.	Week 16

Collaborators and Investigators

• Sponsor: Alma Mater Europaea - Slovenia
• Collaborators: University Clinical Centre of Kosova; University of Pristina

Publications and helpful links

General Publications

• Akcay B, Colak TK, Apti A, Colak I. The Immediate Effect of Hanging Exercise and Muscle Cylinder Exercise on the Angle of Trunk Rotation in Adolescent Idiopathic Scoliosis. Healthcare (Basel). 2024 Jan 24;12(3):305. doi: 10.3390/healthcare12030305.
• Schreiber S, Parent EC, Moez EK, et al. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis. PLoS ONE. 2016;11(6):e0158739.

Helpful Links

• ClinicalTrials.gov official registry platform for clinical trial registration and results database.
• Scoliosis Research Society (SRS) provides evidence-based information and guidelines on scoliosis management and outcomes assessment.
• SOSORT (Society on Scoliosis Orthopaedic and Rehabilitation Treatment) provides international guidelines for conservative scoliosis treatment.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Actual): May 12, 2026
• Study Completion (Estimated): August 12, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 26, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 26, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: physiotherapy; adolescent idiopathic scoliosis; core stabilization; pelvic alignment; spinal posture; spine autocorection exercises; DIERS Formetric 3D/4D
• Other Study ID Numbers: UP-PT-2026-001 (Other Identifier: University of Prishtina - Faculty of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No