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

NCT07736456 | Enrolling By Invitation

• 1 other identifier: UP-PT-2026-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis Idiopathic Adolescent

Keywords

physiotherapy; spine autocorection exercises; core stabilization; spinal posture; pelvic alignment; DIERS Formetric 3D/4D; adolescent idiopathic scoliosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in trunk imbalance

  Week 16

• Change in trunk inclination

  Week 16

• Change in pelvic obliquity

  Week 16

• Change in pelvic torsion

  Week 16

• Change in pelvic rotation

  Week 16

Study Arms (2)

Structured Physiotherapeutic Corrective Exercise Program

EXPERIMENTAL

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

Standard Physiotherapy Exercise Program

ACTIVE COMPARATOR

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

Interventions

Structured Physiotherapeutic Corrective Exercise Program BEHAVIORAL

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.

Structured Physiotherapeutic Corrective Exercise Program

Standard Physiotherapy Exercise Program BEHAVIORAL

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.

Standard Physiotherapy Exercise Program

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alma Mater Europaea - Slovenia: lead
• University of Pristina: collaborator
• University Clinical Centre of Kosova: collaborator

Study Sites (1)

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

Pristina, Kosovo, 10000, Kosovo

Location

Related Publications (2)

• 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.

  PMID: 38338189 BACKGROUND

• Schreiber S, Parent EC, Moez EK, et al. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis. PLoS ONE. 2016;11(6):e0158739.

  BACKGROUND

Related 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either an experimental group receiving a structured physiotherapeutic corrective exercise program or a control group receiving standard physiotherapy care.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 30, 2026
• Study Start: January 12, 2026
• Primary Completion: May 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)