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

NCT07321600 | Recruiting

• 1 other identifier: 20251223
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescence Idiopathic Scoliosis

Keywords

Schroth; Physiotherapeutic scoliosis-specific exercises; Inspiratory muscle training; Adolescent Idiopathic Scoliosis; 3D motion analysis; plantar pressure; PSSE

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and after 8 weeks (24 supervised sessions).

• 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.

  Baseline and after 8 weeks (24 supervised sessions).

• 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).

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

Secondary Outcomes (12)

• Angle of Trunk Rotation (ATR)

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

• Posterior Trunk Symmetry Index (POTSI)

  Baseline and immediately after the 8-week intervention.

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

  Baseline and Week 8

• Health-related Quality of Life - SRS-22

  Baseline and Week 8

• Health-related Quality of Life - ISYQOL

  Baseline and Week 8

Study Arms (2)

PSSE-Schroth + Resistance IMT

EXPERIMENTAL

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.

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

PSSE-Schroth

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: Resistance IMT

PSSE-Schroth + Resistance IMT

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

Also known as: Schroth exercises, PSSE

PSSE-Schroth; PSSE-Schroth + Resistance IMT

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead
• Kirsehir Ahi Evran Universitesi: collaborator

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Merkez, 40100, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an assessor blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Caner KARARTI, Assoc. Prof

Model Details: Two-arm, parallel-group randomized controlled trial comparing PSSE-Schroth plus resistance inspiratory muscle training versus PSSE-Schroth alone. Interventions will be delivered for 8 weeks, 3 sessions/week (total 24 sessions).

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): March 2, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)