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Completed

NCT Number: NCT05381896

The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.

Trunk rotation and distortion of the rib cage, which are common in patients with adolescent idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal muscles. This reduces the capacity of the respiratory muscles to produce force, and results in respiratory muscle weakness. The diaphragm, which is the major respiratory muscle, is also a component of the core muscles responsible for postural stability. Therefore, diaphragm muscle weakness results in deterioration of postural stability. Our aim in this study is to investigate the effect of inspiratory muscle training added to the routine scoliosis exercise program on postural stability and posture perception.

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Key information

Conditions

Adolescent Scoliosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon

Exclusion criteria

  • Having a documented diagnosis of neurological disorders
  • Having a documented diagnosis of mental disorders which may affect cooperation
  • Having a documented diagnosis of chronic airway diseases
  • Having a documented diagnosis of orthopedic disorders which may affect mobility

Treatment and study plan

Conventional Scoliosis Exercise Program

Other

Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.

Inspiratory Muscle Training

Other

Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Primary outcomes

  1. Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

    Time frame: 8 weeks

  2. Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks

    Time frame: 8 weeks

    Walter Reed Visual Assessment Scale evaluates posture perception. It consists of a visual test including seven items that deal with various aspects of the deformity. Each question has a set of five figures that represent degrees of severity of the deformity: spinal deformity, rib prominence, lumbar prominence, thoracic deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry.

  2. Change from baseline maximum inspiratory pressure (MIP) at 8 weeks

    Time frame: 8 weeks

  3. Change from baseline maximum expiratory pressure (MEP) at 8 weeks

    Time frame: 8 weeks

  4. Change from baseline angle of trunk rotation at 8 weeks.

    Time frame: 8 weeks

    Angle of trunk rotation will be evaluated using Bunnell scoliometer in forward bending position

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Bezmialem Vakif University
  • Istanbul Kent University

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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