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

Hacettepe University

Status: Not yet enrolling

Conditions: Adolescence Idiopathic Scoliosis

Treatments: Other: PSSE-Schroth + Resistance IMT; Other: Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

Study type: Interventional

Funder types: Other

Identifiers

NCT07321600

20251223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

45 participants in 2 patient groups

PSSE-Schroth + Resistance IMT

Experimental group

Description:

PSSE-Schroth session will last approximately 45-60 minutes. Exercises will be personalized (by the therapist) according to the individual's curve pattern; emphasis will be placed on the principles of auto-elongation, rotational angular breathing (RAB), derotation, stabilization, and symmetry. Positions will include semi-hanging, prone-on-knees, prone-on-stool, side-lying-on-T-side, side-lying-on-L-side, and supine-tension-with-poles. In addition to PSSE-Schroth exercises, resistance IMT will be applied. Training will be conducted using a threshold-loaded IMT device, maintaining Schroth postural alignment. The program will last eight weeks; three days a week, concurrently with PSSE sessions, each session lasting approximately 15-20 minutes.

Treatment:

Other: Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

Other: PSSE-Schroth + Resistance IMT

PSSE-Schroth

Active Comparator group

Description:

Participants will receive PSSE-Schroth exercises alone for 8 weeks, 3 sessions/week (24 sessions). PSSE-Schroth session will last approximately 45-60 minutes. Exercises will be personalized (by the therapist) according to the individual's curve pattern; emphasis will be placed on the principles of auto-elongation, rotational angular breathing (RAB), derotation, stabilization, and symmetry. Positions will include semi-hanging, prone-on-knees, prone-on-stool, side-lying-on-T-side, side-lying-on-L-side, and supine-tension-with-poles.

Treatment:

Other: Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)