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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Scoliosis Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sham Group

IMT (Sham) and Schroth therapy

Group Type SHAM_COMPARATOR

Inspiratory Muscle Training (Sham)

Intervention Type 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.

IMT Group

IMT and Schroth therapy

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type 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.

Interventions

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Inspiratory Muscle Training

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aleksandra Grudzińska

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR