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NCT Number: NCT07552662

Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises With Idiopathic Scoliosis

This randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period. Primary outcomes include Cobb angle progression and brace prescription rate. Secondary outcomes include trunk rotation, quality of life, self-image, and body symmetry.

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Key information

Conditions

Scoliosis Idiopathic Behavior Exercise Motor Activity Scroth

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

About this study

Adolescent idiopathic scoliosis is a three-dimensional spinal deformity that may progress during growth. Although PSSE is increasingly recommended in conservative scoliosis management, comparative randomized evidence remains limited. This study aims to compare PSSE-Schroth exercises with General Exercises in adolescents with mild idiopathic scoliosis over 12 months. Participants are randomized into intervention or control groups receiving matched exercise dosage and supervision. Outcomes assess radiographic progression, trunk rotation, need for bracing, and patient-reported clinical parameters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of adolescent idiopathic scoliosis
  • Cobb angle 10°-25°
  • Risser sign 0-3 ATR >5°
  • Less than 1 year post-menarche (for females)

Exclusion criteria

  • Previous brace treatment * Non-idiopathic scoliosis
  • Previous scoliosis surgery
  • Neuromuscular or congenital scoliosis

Treatment and study plan

PSSE-Schroth Exercises

Other

Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training

General exercises

Other

Participants performed general strengthening and stretching exercises without scoliosis-specific correction.

Primary outcomes

  1. Change in Cobb Angle

    Time frame: Baseline to 12 Months

    Cobb angle will be measured on standing anteroposterior spinal radiographs using the standard Cobb method. The angle is defined as the intersection of lines drawn parallel to the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the primary curve. Measurements will be performed at baseline and after the intervention period, and the change in Cobb angle (in degrees) will be calculated. Lower values indicate an improvement in spinal curvature.

  2. Brace Prescription Rate

    Time frame: 12 Months

    The proportion of participants requiring orthotic bracing during the study period will be recorded. Brace prescription will be determined by a specialist according to established clinical criteria (e.g., curve magnitude, skeletal maturity, and risk of progression). The rate will be expressed as the percentage of participants prescribed a brace in each group during the follow-up period.

Secondary outcomes

  1. SRS-22 Questionnaire Score

    Time frame: Baseline to 12 Months

    Health-related quality of life will be assessed using the Scoliosis Research Society-22 Questionnaire (SRS-22). This validated instrument includes five domains: function/activity, pain, self-image/appearance, mental health, and satisfaction with management. Each item is scored on a 5-point Likert scale, with higher scores indicating better health status. Assessments will be performed at baseline and after the intervention period, and changes in domain and total scores will be analyzed.

  2. TAPS Score

    Time frame: Baseline to 12 Months

    Trunk appearance will be assessed using the Trunk Appearance Perception Scale (TAPS). This patient-reported outcome measure evaluates subjective perception of trunk deformity using a set of standardized drawings viewed from different perspectives. Each item is scored on a Likert scale, with higher scores indicating better perceived trunk appearance (less deformity). Assessments will be conducted at baseline and after the intervention period, and changes in TAPS scores will be analyzed.

  3. TRACE Score

    Time frame: Baseline to 12 Months

    Clinical trunk deformity will be assessed using the Trunk Aesthetic Clinical Evaluation (TRACE) scale. This clinician-rated tool evaluates visible asymmetries of the shoulders, scapulae, waist, and hemithorax. Each domain is scored based on the severity of asymmetry, and a total score is calculated, with higher scores indicating greater aesthetic deformity. Assessments will be performed at baseline and after the intervention period, and changes in TRACE scores will be analyzed.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises Versus General Exercises in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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