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

February 21, 2023 updated by: Melih Zeren, Izmir Bakircay University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Patients in this group will receive conventional scoliosis exercise program for 1 hour, 6 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Other: Conventional Scoliosis Exercise Program
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Experimental: Training Group
In addition to the conventional scoliosis exercise program, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 6 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Other: Conventional Scoliosis Exercise Program
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Other: Inspiratory Muscle Training
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame: 8 weeks
8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Time Frame: 8 weeks
8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Time Frame: 8 weeks
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Collaborators

Bezmialem Vakif University
Istanbul Kent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Actual)

December 23, 2022

Study Completion (Actual)

December 23, 2022

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bakircaymzeren06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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