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NCT Number: NCT07321600

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

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.

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Key information

Conditions

Adolescence Idiopathic Scoliosis

Age range

10 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran University

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Caner Karartı

CONTACT

[email protected]

03862805362

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female adolescents aged 10-18 years.

Diagnosis of adolescent idiopathic scoliosis (AIS).

Cobb angle between 10° and 45°.

Angle trunk rotation (ATR) ≥ 5°.

Risser ≤ 3 and Sanders ≤ 4.

No scoliosis-related procedure within the last 6 months.

No contraindication to exercise.

Exclusion criteria

Non-idiopathic scoliosis (neuromuscular, congenital, syndromic).

Inability to achieve ≥80% adherence/compliance.

History of spinal surgery or major trauma.

Cardiopulmonary diseases contraindicating exercise.

Neurological, rheumatological, vestibular, or systemic diseases.

Acute musculoskeletal injury or impaired skin integrity.

Participation in a regular PSSE-Schroth or IMT program within the last 3 months.

Intellectual disability or communication difficulties preventing protocol adherence.

Newly initiated brace treatment or high risk of non-compliance with brace management.

Lack of informed consent.

Treatment and study plan

Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

Other

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 names: Schroth exercises, PSSE

PSSE-Schroth + Resistance IMT

Other

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

Other names: Resistance IMT

Primary outcomes

  1. Six-Minute Walk Test

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

    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.

  2. Change in Cobb Angle

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

    Cobb angle will be measured on standard standing posteroanterior radiographs. The primary outcome is the change in Cobb angle from baseline to post-intervention.

  3. Respiratory muscle strength - maximal inspiratory pressure (MIP)

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

    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

  1. Angle of Trunk Rotation (ATR)

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

    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.

  2. Posterior Trunk Symmetry Index (POTSI)

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

    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.

  3. Walter Reed Visual Assessment Scale - Turkish version (WRVAS-TR)

    Time frame: Baseline and Week 8

    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.

  4. Health-related Quality of Life - SRS-22

    Time frame: Baseline and Week 8

    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.

  5. Health-related Quality of Life - ISYQOL

    Time frame: Baseline and Week 8

    Health-related quality of life will be assessed using the Italian Spine Youth Quality of Life (ISYQOL) questionnaire. Change in total score from baseline to after the 8-week intervention will be analyzed.

  6. Sleep quality (Pittsburgh Sleep Quality Index)

    Time frame: Baseline and Week 8

    Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The outcome will be the change in PSQI global score from baseline to after the intervention.

  7. Daytime sleepiness (Epworth Sleepiness Scale)

    Time frame: Baseline and Week 8

    Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (adult or child/adolescent version, as appropriate). The outcome will be the change in total score from baseline to after the 8-week intervention and comparison between groups.

  8. Trunk muscle activation (surface EMG)

    Time frame: Baseline and Week 8

    Trunk muscle activation patterns will be evaluated using surface electromyography (sEMG) from selected trunk muscles during standardized postural or functional tasks. The outcome will be the change in normalized EMG activity from baseline to after the 8-week intervention

  9. Spinal and pelvic kinematics (3D motion analysis)

    Time frame: Baseline and Week 8

    Three-dimensional motion analysis will be used to quantify spinal and pelvic kinematics during standardized tasks. The outcome will be the change in relevant kinematic parameters from baseline to after the 8-week intervention.

  10. Plantar pressure distribution (baropodometric analysis)

    Time frame: Baseline and Week 8

    Plantar pressure distribution and load symmetry will be assessed using a baropodometric platform. The outcome will be the change in plantar pressure variables (e.g., forefoot-rearfoot loading and left-right symmetry) from baseline to after the 8-week intervention.

  11. Knee muscle strength (isokinetic quadriceps and hamstrings)

    Time frame: Baseline and Week 8

    Knee extensor (quadriceps) and flexor (hamstring) muscle strength will be measured using an isokinetic dynamometer during concentric knee flexion and extension. The outcome will be the change in peak torque (normalized to body mass) from baseline to after the 8-week intervention.

  12. Postural Control Assessment

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

    Individuals' postural control in static-eyes open, static-eyes closed, and dynamic positions will be measured using the Korebalance® System. The Korebalance® System is a computerised platform that combines balance assessment with exercise, providing a technologically advanced solution for balance-related concerns.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Kirsehir Ahi Evran Universitesi

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Mar 3, 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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