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Recruiting NCT07321600

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

No phase Interventional Adolescence Idiopathic Scoliosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth), PSSE-Schroth + Resistance IMT.
Who it may be relevant to
Registry conditions: Adolescence Idiopathic Scoliosis. Basic parameters: 10 years — 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Six-Minute Walk Test [Time frame: Baseline and after 8 weeks (24 supervised sessions).]
  • Change in Cobb Angle [Time frame: Baseline and after 8 weeks (24 supervised sessions).]
  • Respiratory muscle strength - maximal inspiratory pressure (MIP) [Time frame: Baseline and Week 8 (end of 24 supervised sessions).]
Secondary outcome measures (12)
  • Angle of Trunk Rotation (ATR) [Time frame: Baseline and immediately after the 8-week intervention (24 sessions)]
  • Posterior Trunk Symmetry Index (POTSI) [Time frame: Baseline and immediately after the 8-week intervention.]
  • Walter Reed Visual Assessment Scale - Turkish version (WRVAS-TR) [Time frame: Baseline and Week 8]
  • Health-related Quality of Life - SRS-22 [Time frame: Baseline and Week 8]
  • Health-related Quality of Life - ISYQOL [Time frame: Baseline and Week 8]
  • Sleep quality (Pittsburgh Sleep Quality Index) [Time frame: Baseline and Week 8]
  • Daytime sleepiness (Epworth Sleepiness Scale) [Time frame: Baseline and Week 8]
  • Trunk muscle activation (surface EMG) [Time frame: Baseline and Week 8]
  • Spinal and pelvic kinematics (3D motion analysis) [Time frame: Baseline and Week 8]
  • Plantar pressure distribution (baropodometric analysis) [Time frame: Baseline and Week 8]
  • Knee muscle strength (isokinetic quadriceps and hamstrings) [Time frame: Baseline and Week 8]
  • Postural Control Assessment [Time frame: Baseline and after 8 weeks (24 supervised sessions).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kırşehir Ahi Evran University — Kırşehir

Identifiers

NCT: NCT07321600 · 20251223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗