About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)
Other interventionParticipants 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
PSSE-Schroth + Resistance IMT
Other interventionParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Six-Minute Walk Test
The Six-Minute Walk Test (6MWT) is a tool designed to assess functional exercise capacity, with a particular focus on individuals suffering from cardiopulmonary conditions. The distance walked in six minutes on a flat, straight course, typically 30 metres long, is recorded. The distance measured reflects submaximal exercise capacity. The 6MWT is a valuable tool in the assessment of disease progression, the evaluation of rehabilitation outcomes, and the determination of treatment response.
Change in Cobb Angle
Cobb angle will be measured on standard standing posteroanterior radiographs. The primary outcome is the change in Cobb angle from baseline to post-intervention.
Respiratory muscle strength - maximal inspiratory pressure (MIP)
Maximal inspiratory pressure (cmH₂O) will be measured using a digital manometer. The primary outcome is the change in MIP from baseline to after the 8-week intervention, and the between-group difference in this change (PSSE-Schroth + resistance IMT vs PSSE-Schroth alone).
Secondary outcomes
Angle of Trunk Rotation (ATR)
Angle of trunk rotation will be measured using a Bunnell scoliometer during the forward bend test. The outcome will be reported as change from baseline to post-intervention and compared between groups.
Posterior Trunk Symmetry Index (POTSI)
Posterior trunk symmetry will be evaluated using the Posterior Trunk Symmetry Index (POTSI). Change from baseline to post-intervention will be analyzed to assess the effect of adding inspiratory muscle training to PSSE-Schroth.
Walter Reed Visual Assessment Scale - Turkish version (WRVAS-TR)
Perceived trunk deformity will be assessed with the Turkish version of the Walter Reed Visual Assessment Scale (WRVAS-TR). The outcome will be the change in total score from baseline to after the intervention.
Health-related Quality of Life - SRS-22
Health-related quality of life will be assessed using the Scoliosis Research Society-22 questionnaire. The outcome will be the change in total and domain scores from baseline to after the intervention.
Sponsors and contacts
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Hacettepe University
Lead sponsor
Kirsehir Ahi Evran Universitesi
Collaborator