Back to resultsThe Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Primary Purpose
Adolescent Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Scoliosis Exercise Program
Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Scoliosis focused on measuring postural stability, posture perception, inspiratory muscle training, adolescent idiopathic scoliosis
Eligibility Criteria
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
Sites / Locations
- Bezmialem Vakif University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Training Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Secondary Outcome Measures
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.
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Change from baseline angle of trunk rotation at 8 weeks.
Angle of trunk rotation will be evaluated using Bunnell scoliometer in forward bending position
Full Information
NCT ID
NCT05381896
First Posted
May 16, 2022
Last Updated
February 21, 2023
Sponsor
Izmir Bakircay University
Collaborators
Bezmialem Vakif University, Istanbul Kent University
1. Study Identification
Unique Protocol Identification Number
NCT05381896
Brief Title
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Official Title
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Bezmialem Vakif University, Istanbul Kent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Scoliosis
Keywords
postural stability, posture perception, inspiratory muscle training, adolescent idiopathic scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Scoliosis Exercise Program
Intervention Description
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Primary Outcome Measure Information:
Title
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame
8 weeks
Title
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Time Frame
8 weeks
Title
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Time Frame
8 weeks
Title
Change from baseline angle of trunk rotation at 8 weeks.
Description
Angle of trunk rotation will be evaluated using Bunnell scoliometer in forward bending position
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
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