On January 10, 2026, Hacettepe University and Kirsehir Ahi Evran Universitesi announced a new clinical trial investigating the combined effects of resistance inspiratory muscle training (IMT) with Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) in adolescents with idiopathic scoliosis. While recruitment has not yet begun, this study aims to explore advanced physical therapy interventions targeting spinal deformities and respiratory health in scoliosis patients.
What changed?
Resistance inspiratory muscle training (IMT) is being introduced alongside PSSE-Schroth exercises in a clinical trial targeting idiopathic scoliosis in adolescents. The trial represents a focus on innovative physical therapy methods. Resistance IMT aims to strengthen ventilatory muscles, while Schroth exercises are designed to correct spinal asymmetries and improve posture. Together, these interventions could offer a comprehensive strategy to address both musculoskeletal and respiratory outcomes associated with scoliosis.
Who is affected?
This trial specifically targets adolescents diagnosed with idiopathic scoliosis. Scoliosis is a condition where the spine curves abnormally, often leading to postural issues and respiratory challenges. Adolescents undergoing physical therapy for scoliosis may benefit from integrative strategies combining muscle-strengthening respiratory interventions with established scoliosis-specific exercises. This study is particularly relevant for clinicians, physiotherapists, and health regulators focused on improving scoliosis care.
Regulatory considerations
Sponsored by Hacettepe University and Kirsehir Ahi Evran Universitesi, the project’s design reflects compliance with clinical trial regulations. For trials involving multiple physical therapy modalities, clear documentation of participant safety and device efficacy is critical. The introduction of novel techniques such as resistance IMT requires robust oversight to align with global regulations, particularly MDR Annex XIV guidance on medical interventions.
While the trial is not yet recruiting, professionals engaged in regulatory affairs should monitor updates, especially regarding patient eligibility, trial outcomes, and the impact of combined therapy interventions. Detailed protocol review could also influence future regulatory pathways for similar therapies.
Frequently Asked Questions
1. What are Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth)?
PSSE-Schroth exercises are physical therapy techniques designed to correct spinal alignment, improve posture, and reduce discomfort caused by scoliosis.
2. What is resistance inspiratory muscle training?
Resistance IMT involves using devices or techniques to strengthen respiratory muscles. It improves overall ventilatory function, particularly in patients with conditions affecting breathing.
3. Do these interventions require medical devices?
Yes, IMT typically involves specialized devices to create resistance during breathing. PSSE-Schroth may incorporate therapeutic tools but mainly relies on physical guidance.
4. When will recruitment start?
The trial is currently marked as ‘Not yet recruiting,’ indicating future enrollment dates will be announced by the sponsoring institutions.
Conclusion
This upcoming clinical trial merges respiratory muscle training with scoliosis-targeted exercises, potentially advancing therapeutic options for scoliosis care. Stakeholders in clinical trials, physical therapy, and regulatory domains should stay informed for recruitment and early findings.
Disclaimer
This publication is for informational purposes only. It is not legal advice or professional healthcare guidance. Always refer to official trial documentation and regulatory agencies for decisions.
Full study details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07321600?term=medical+device