Scoliosis IdiopathicNCT07177430
Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.
A study testing Inspiratory Muscle Training in people with Scoliosis Idiopathic, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesPoland
- Study dates
- 13 Oct 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- chronic respiratory diseases,
- inhalant allergies,
- limited contact with the patient, preventing the examination from being performed;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Centrum Skolioz- Centrum Diagnostyczno-Rehabilitacyjne Promyk Słońca
Wroclaw, Lower Silesian Voivodeship, 50-088
Aleksandra Grudzińska, MSc, 503676949, +48, aleksandra.grudzinska@awf.wroc.pl
- Recruiting
Wroclaw University of Health and Sport Sciences
Wroclaw, Lower Silesian Voivodeship, 51-612
Aleksandra Grudzińska, MSc, 503676949, +48, aleksandra.grudzinska@awf.wroc.pl
About this study
Official title: The Effect of Inspiratory Muscle Training on Respiratory Function, Exercise Tolerance and Core Stability in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.
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
- Being tested
- Inspiratory Muscle Training, Inspiratory Muscle Training (Sham)
- Keywords
- Inspiratory Muscle Training, Schroth method, Exercise tolerance, Core stability, Respiratory function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | IMT (Sham) and Schroth therapy Receives: Device: Inspiratory Muscle Training (Sham) |
| IMT Group | Experimental | IMT and Schroth therapy Receives: Device: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks (post-intervention)
Secondary outcomes (1)
Physical activity
Physical activity levels will be assessed using the PAQ-C (Physical Activity Questionnaire for Children) or PAQ-A (Physical Activity Questionnaire for Adolescents). This questionnaire gathers information on the frequency and intensity of physical activities, including sports, outdoor play, and other forms of exercise. Higher scores indicate greater levels of physical activity.
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start13 Oct 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Grudzińska, Wroclaw University of Health and Sport Sciences
- Investigators
- Krystyna Rożek-Piechura, Professor, Study director, Wroclaw University of Health and Sport Sciences, PolandAleksandra Grudzińska, MSc, Principal investigator, Wroclaw University of Health and Sport Sciences, PolandElżbieta Piątek-Krzywicka, PhD, Principal investigator, Wroclaw University of Health and Sport Sciences, PolandAnna Badowska, MD, Principal investigatorJerzy R Piechura, PhD, Principal investigator, Wroclaw University of Health and Sport Sciences, PolandPaulina Okrzymowska, PhD, Principal investigator, Wroclaw University of Health and Sport Sciences, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177430
- Sponsor's protocol ID
- WroclawUHSS Ethics (22/2025)
- Status last verified
- Nov 2025
- First submitted
- 29 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Respiratory Function, Exercise Tolerance and Core Stability in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.
- ClinicalTrials.gov ID
- NCT07177430
- Acronym / sponsor ID
- WroclawUHSS Ethics (22/2025)
- Conditions
- Scoliosis Idiopathic
- Keywords
- Inspiratory Muscle Training, Schroth method, Exercise tolerance, Core stability, Respiratory function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Device: Inspiratory Muscle Training (Sham)IMT (Sham) and Schroth therapy |
| IMT Group | Experimental | Device: Inspiratory Muscle TrainingIMT and Schroth therapy |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- chronic respiratory diseases,
- inhalant allergies,
- limited contact with the patient, preventing the examination from being performed;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingParticipants 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. | Device | IMT Group |
| Inspiratory Muscle Training (Sham)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. | Device | Sham Group |
Primary outcome
Pulmonary function test
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Pulmonary function test (Maximal inspiratory flow at 50% of FVC (MIF50))
Time frame: Baseline and after 8 weeks (post-intervention)
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).
Pulmonary function test (MEF50/MIF50 ratio)
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Measurement of maximal inspiratory and expiratory pressure
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Forced oscillation technique (FOT)
Time frame: Baseline and after 8 weeks (post-intervention)
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).
Six-minute walk test (6MWT)
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Isokinetic dynamometry (Peak torque)
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Isokinetic dynamometry (Total work)
Time frame: Baseline and after 8 weeks (post-intervention)
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.
Isokinetic dynamometry (Average power)
Time frame: Baseline and after 8 weeks (post-intervention)
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.
1 secondary outcome
Physical activity
Time frame: Before intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krystyna Rożek-Piechura, Professor study director
Wroclaw University of Health and Sport Sciences, Poland
Aleksandra Grudzińska, MSc principal investigator
Wroclaw University of Health and Sport Sciences, Poland
Elżbieta Piątek-Krzywicka, PhD principal investigator
Wroclaw University of Health and Sport Sciences, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Scoliosis Idiopathic, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Grudzińska, MSc (503676949, +48, aleksandra.grudzinska@awf.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: Baseline and after 8 weeks (post-intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.