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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05381896
Other study ID # Bakircaymzeren06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2022
Est. completion date December 23, 2022

Study information

Verified date February 2023
Source Izmir Bakircay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 23, 2022
Est. primary completion date December 23, 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional Scoliosis Exercise Program
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Inspiratory Muscle Training
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Izmir Bakircay University Bezmialem Vakif University, Istanbul Kent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks 8 weeks
Primary Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks 8 weeks
Secondary Change from baseline "Walter Reed Visual Assessment Scale" at 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. 8 weeks
Secondary Change from baseline maximum inspiratory pressure (MIP) at 8 weeks 8 weeks
Secondary Change from baseline maximum expiratory pressure (MEP) at 8 weeks 8 weeks
Secondary Change from baseline angle of trunk rotation at 8 weeks. Angle of trunk rotation will be evaluated using Bunnell scoliometer in forward bending position 8 weeks
See also
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Recruiting NCT06314594 - the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis N/A