Adolescent ScoliosisNCT05381896
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
A study testing Conventional Scoliosis Exercise Program and Inspiratory Muscle Training in people with Adolescent Scoliosis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Scoliosis
- What is being tested?
- Conventional Scoliosis Exercise Program and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2022to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Adolescent Scoliosis
- Being tested
- Conventional Scoliosis Exercise Program, Inspiratory Muscle Training
- Keywords
- postural stability, posture perception, inspiratory muscle training, adolescent idiopathic scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Scoliosis Exercise ProgramOther
Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.
Inspiratory Muscle TrainingOther
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Conventional Scoliosis Exercise Program |
| Training Group | Experimental | 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. Receives: Other: Conventional Scoliosis Exercise Program; Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Measured: 8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Measured: 8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start23 May 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Istanbul Kent University
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381896
- Sponsor's protocol ID
- Bakircaymzeren06
- Status last verified
- Feb 2023
- First submitted
- 16 May 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
- ClinicalTrials.gov ID
- NCT05381896
- Acronym / sponsor ID
- Bakircaymzeren06
- Conditions
- Adolescent Scoliosis
- Keywords
- postural stability, posture perception, inspiratory muscle training, adolescent idiopathic scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University, Istanbul Kent University
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Scoliosis Exercise ProgramPatients 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 | Experimental | Other: Conventional Scoliosis Exercise Program, Other: Inspiratory Muscle TrainingIn 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Scoliosis Exercise ProgramProgram will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises. | Other | Control Group, Training Group |
| Inspiratory Muscle TrainingThreshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure. | Other | Training Group |
Primary outcome
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time frame: 8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time frame: 8 weeks
4 secondary outcomes
Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks
Time frame: 8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Time frame: 8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Time frame: 8 weeks
Change from baseline angle of trunk rotation at 8 weeks.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Scoliosis Exercise Program and Inspiratory Muscle Training in people with Adolescent Scoliosis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.