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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age10-18
SponsorHacettepe University

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

    Other intervention

    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

  • PSSE-Schroth + Resistance IMT

    Other intervention

    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

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: PSSE-Schroth + Resistance IMTExperimental treatment 2 interventions
Group B: PSSE-SchrothActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and after 8 weeks (24 supervised sessions).
2

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.

Time frame
Baseline and after 8 weeks (24 supervised sessions).
3

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).

Time frame
Baseline and Week 8 (end of 24 supervised sessions).

Secondary outcomes

1

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.

Time frame
Baseline and immediately after the 8-week intervention (24 sessions)
2

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.

Time frame
Baseline and immediately after the 8-week intervention.
3

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.

Time frame
Baseline and Week 8
4

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.

Time frame
Baseline and Week 8

Other outcomes

Sponsors and contacts

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Hacettepe University

Lead sponsor

Kirsehir Ahi Evran Universitesi

Collaborator