Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

NCT07177430 | Recruiting

• 1 other identifier: WroclawUHSS Ethics (22/2025)
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effectiveness of inspiratory muscle training in children and adolescents with idiopathic scoliosis undergoing therapy with the Schroth method. The intervention- inspiratory muscle training- aims to improve respiratory function, increase exercise tolerance, and strengthen core stability in the participants. The proposed training may enhance the effectiveness of therapy conducted using the Schroth method and improve participants' performance in activities of daily living. The project aims to assess the impact of inspiratory muscle training in children and adolescents with idiopathic scoliosis on respiratory system function, exercise tolerance, and core stability.

Conditions

Scoliosis Idiopathic

Keywords

Inspiratory Muscle Training; Schroth method; Exercise tolerance; Core stability; Respiratory function

Outcome Measures

Primary Outcomes (9)

• Pulmonary function test

  Assessment of pulmonary ventilation will be performed using pulmonary function testing with a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. The data collected for analysis will include the following parameters: vital capacity (VC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), maximal expiratory flow at 50% of forced vital capacity (MEF50). Unite of measurements: all measurements are taken as a percentage from predicted.

  Baseline and after 8 weeks (post-intervention)

• Pulmonary function test (Maximal inspiratory flow at 50% of FVC (MIF50))

  Pulmonary function test will be performed using a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. Maximal inspiratory flow at 50% of FVC (MIF50) is expressed in litres per second (l/s).

  Baseline and after 8 weeks (post-intervention)

• Pulmonary function test (MEF50/MIF50 ratio)

  Pulmonary function test will be performed using a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. The MEF50/MIF50 ratio is a dimensionless value (because in this case the MEF50 value is expressed in l/s, similarly to MIF50). This indicator assesses airway patency. It is mainly used for the diagnosis and differentiation of upper airway stenosis.

  Baseline and after 8 weeks (post-intervention)

• Measurement of maximal inspiratory and expiratory pressure

  Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressure. The test is non-invasive and will be performed using a pneumatic adapter connected to the tachometer of the device used for pulmonary function testing. The assessment will be conducted in accordance with ATS/ERS guidelines; following the recommended procedure, 5 to 10 measurements will be taken, from which the three highest values will be selected. Based on the results of this test, the training parameters for the planned intervention will be determined.

  Baseline and after 8 weeks (post-intervention)

• Forced oscillation technique (FOT)

  To provide information on the mechanical and elastic properties of the respiratory system, the forced oscillation technique (FOT) will be performed. For this purpose, the Resmon Pro V3 device (MGC Diagnostics®) will be used, employing the built-in pediatric mode that applies an 8 Hz signal frequency. The main parameters analyzed will be resistance (Rrs) and reactance (Xrs).

  Baseline and after 8 weeks (post-intervention)

• Six-minute walk test (6MWT)

  This test will be used to assess cardiorespiratory fitness. The examination will be conducted in accordance with the American Thoracic Society guidelines for this test. The parameter analyzed will be the distance covered by the participants.

  Baseline and after 8 weeks (post-intervention)

• Isokinetic dynamometry (Peak torque)

  Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). The evaluated parameter, peak torque, represents the maximum recorded torque produced by the analyzed muscle group at a specified angular velocity, expressed in newton-meters (N·m). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.

  Baseline and after 8 weeks (post-intervention)

• Isokinetic dynamometry (Total work)

  Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). Total work is the work performed by the muscles throughout all movements executed during the task. It also allows for the assessment of muscle endurance. This parameter is expressed in joules (J). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.

  Baseline and after 8 weeks (post-intervention)

• Isokinetic dynamometry (Average power)

  Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). Average power is a parameter calculated by dividing the work performed during a single repetition by the duration of the movement. Its values are expressed in watts (W). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.

  Baseline and after 8 weeks (post-intervention)

Secondary Outcomes (1)

• Physical activity

  Before intervention

Study Arms (2)

Sham Group

SHAM COMPARATOR

IMT (Sham) and Schroth therapy

Device: Inspiratory Muscle Training (Sham)

IMT Group

EXPERIMENTAL

IMT and Schroth therapy

Device: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training DEVICE

Participants will perform inspiratory muscle training using a respiratory muscle trainer. The initial training load will be set at 30% of PImax. The intervention will last for 8 weeks and will be carried out 5 days per week, twice daily, in 3 sets of 10 repetitions. The training load will be increased in the 2nd, 4th, and 6th week of the program, each time by an additional 10% relative to the initial PImax.

IMT Group

Inspiratory Muscle Training (Sham) DEVICE

The training intervention in the Sham Group will differ from the experimental group only in terms of training load. This load will remain constant at 15% PImax, which does not cause any changes in the functioning of the inspiratory muscles. All other training parameters will be identical to those in the IMT group.

Sham Group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed idiopathic scoliosis,
• age: 11-16 years (girls after their first period, boys after voice mutation),
• spinal curvature angle \> 20° according to Cobb,
• guardian's consent to participate in the study;

You may not qualify if:

• chronic respiratory diseases,
• inhalant allergies,
• limited contact with the patient, preventing the examination from being performed;

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (2)

Centrum Skolioz- Centrum Diagnostyczno-Rehabilitacyjne Promyk Słońca

Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

RECRUITING

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Krystyna Rożek-Piechura, Professor

  Wroclaw University of Health and Sport Sciences, Poland

  STUDY DIRECTOR

• Aleksandra Grudzińska, MSc

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Elżbieta Piątek-Krzywicka, PhD

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Anna Badowska, MD

  PRINCIPAL INVESTIGATOR

• Jerzy R Piechura, PhD

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Paulina Okrzymowska, PhD

  Wroclaw University of Health and Sport Sciences, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Grudzińska, MSc

CONTACT

503676949, +48; aleksandra.grudzinska@awf.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 17, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

PL (2)