NCT07321600

Resisted Inspiratory Muscle Training Applied in Addition to PSSE-Schroth Exercises

The Effects of Resisted Inspiratory Muscle Training Applied in Addition to PSSE-Schroth Exercises on Clinical Outcomes in Individuals With Adolescent Idiopathic Scoliosis.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: Female
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized controlled trial will evaluate whether adding resisted inspiratory muscle training (IMT) to Physiotherapeutic Scoliosis-Specific Exercises (PSSE)-Schroth exercises provides additional benefits on clinical outcomes in individuals with adolescent idiopathic scoliosis. Participants will be randomly assigned to either PSSE-Schroth plus IMT or PSSE-Schroth alone. Both groups will receive supervised exercise sessions three times per week for 8 weeks (24 sessions). Outcomes will be assessed before and after the intervention and will include clinical measures (e.g., Cobb angle, angle of trunk rotation, Posterior Trunk Symmetry Index, The Walter Reed Visual Assessment Scale), respiratory muscle performance (maximal inspiratory pressure/maximal expiratory pressure, six-minute walk test) and related physiological parameters, functional performance (balance, 3D kinematics, plantar pressure analysis, isokinetic strength), sleep quality, and health-related quality of life (Scoliosis Research Society- 22, Italian Spine Youth Quality of Life). The study is expected to enroll approximately 45 participants.

Detailed description

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may adversely affect thoracic volume, respiratory mechanics, postural symmetry, balance, functional capacity, and health-related quality of life. While physiotherapeutic scoliosis-specific exercises (PSSE), including the Schroth method, have demonstrated clinical benefit, the evidence regarding the added value of integrating structured inspiratory muscle training (IMT) with PSSE remains limited, particularly in studies using comprehensive physiological and biomechanical outcome sets. This prospective, randomized controlled trial will investigate whether adding resisted IMT to a standardized PSSE-Schroth program provides additional improvements in clinical outcomes in adolescents with AIS. Eligible participants will be females aged 10-18 years diagnosed with AIS, with Cobb angle between 10° and 45°, angle trunk rotation (ATR) ≥5°, and skeletal immaturity criteria consistent with Risser ≤3 and Sanders ≤4. Participants with non-idiopathic scoliosis, recent spine surgery/major trauma, contraindications to exercise, relevant systemic/neurological conditions, or recent participation in PSSE/IMT programs will be excluded. Participants will be randomly allocated to one of two groups: (1) PSSE-Schroth plus resistance IMT or (2) PSSE-Schroth alone. Both groups will receive supervised sessions for 8 weeks, three times per week (total 24 sessions). The independent variable is the exercise protocol, and dependent variables include clinical measures. The trial aims to provide a multidimensional evaluation of the potential additive effects of IMT when integrated with PSSE-Schroth, offering clinically relevant evidence to refine conservative rehabilitation strategies for AIS.

Conditions

• Adolescence Idiopathic Scoliosis

Interventions

Type	Name	Description
OTHER	Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)	Participants will perform a standardized PSSE-Schroth exercise program under supervision. Sessions will be delivered three times per week for 8 weeks (total 24 sessions). Exercises will be individualized according to scoliosis pattern and clinical assessment
OTHER	PSSE-Schroth + Resistance IMT	Participants will receive threshold-loaded inspiratory muscle training in addition to PSSE-Schroth. IMT will be supervised and performed three times per week for 8 weeks, aligned with the exercise sessions. Training will be progressed according to individual tolerance and protocol targets

Timeline

• Start date: 2026-01-02
• Primary completion: 2026-12-02
• Completion: 2027-03-02
• First posted: 2026-01-07
• Last updated: 2026-03-03

Locations

1 site across 1 country: Turkey (Türkiye)