The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedFebruary 22, 2023
February 1, 2023
7 months
May 16, 2022
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
8 weeks
Secondary Outcomes (4)
Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks
8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
8 weeks
Change from baseline angle of trunk rotation at 8 weeks.
8 weeks
Study Arms (2)
Control Group
ACTIVE COMPARATORPatients 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.
Training Group
EXPERIMENTALIn 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.
Interventions
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Eligibility Criteria
You may qualify if:
- Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Izmir Bakircay Universitylead
- Bezmialem Vakif Universitycollaborator
- Istanbul Kent Universitycollaborator
Study Sites (1)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asst. prof.
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 19, 2022
Study Start
May 23, 2022
Primary Completion
December 23, 2022
Study Completion
December 23, 2022
Last Updated
February 22, 2023
Record last verified: 2023-02