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

NCT ID: NCT07321600

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2027-03-02

Brief Summary

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.

Conditions

Adolescence Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PSSE-Schroth + Resistance IMT

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.

Group Type: EXPERIMENTAL

Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

Intervention Type: 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

PSSE-Schroth + Resistance IMT

Intervention Type: 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

PSSE-Schroth

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.

Group Type: ACTIVE_COMPARATOR

Physiotherapeutic scoliosis-specific exercises (PSSE-Schroth)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Schroth exercises; PSSE; Resistance IMT

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Caner Karartı

Caner KARARTI, Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kırşehir Ahi Evran University

Kırşehir, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Facility Contacts

Caner Karartı

Role: primary

canerkararti@ahievran.edu.tr

03862805362

Other Identifiers

20251223

Identifier Type: -

Identifier Source: org_study_id