Adolescent Idiopathic ScoliosisNCT05833425
Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Scoliosis?
An observational study of Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic… Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Respiratory Pressure Meter (MicroRPM)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Dec 2023
- Phase
- Observational
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: It was calculated that at least 36 patients in total, 18 patients in the scoliosis and healthy groups, should be included in the study.
Who may be able to join
- Individuals agreeing to participate in the study
- In the age range of 10-20
- Patients with scoliosis with a Cobb angle of 10-40 degrees measured on X-Ray
Who cannot join
- Surgical operation in the last 3 months
- Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Eyüp, 34050
About this study
Official title: Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Adolescent Idiopathic Scoliosis?
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body.
The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Respiratory Pressure Meter (MicroRPM)
- Keywords
- Scoliosis, Adolescent Idiopathic Scoliosis, Respiratory Muscle Strength, Peripheral Muscle Strength, Postural Control
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Pressure Meter (MicroRPM)Device
Also called Biodex Balance System®
Peripheral muscle strength, respiratory muscle strength and postural controls of all adolescents will be evaluated. The values of the scoliotic and healthy groups will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis group | In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all scoliosis adolescent. Receives: Device: Respiratory Pressure Meter (MicroRPM) | |
| Healthy group | In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all healthy adolescent. Receives: Device: Respiratory Pressure Meter (MicroRPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
Respiratory muscle strength will be made with a portable, electronic intraoral pressure measuring device.
Measured: Baseline
Peripheral Muscle Strength
Peripheral muscle strength will be performed using an electronic dynamometer.
Measured: Baseline
Postural Control
Postural Stability and Balance will be evaluated with the Biodex Balance System®.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833425
- Sponsor's protocol ID
- BVUsyildirim02
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2023
- Last updated
- 7 Aug 2026
- Results posted
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Adolescent Idiopathic Scoliosis?
- ClinicalTrials.gov ID
- NCT05833425
- Acronym / sponsor ID
- BVUsyildirim02
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Adolescent Idiopathic Scoliosis, Respiratory Muscle Strength, Peripheral Muscle Strength, Postural Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Apr 2023 (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.
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body.
The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis group | – | Device: Respiratory Pressure Meter (MicroRPM)In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all scoliosis adolescent. |
| Healthy group | – | Device: Respiratory Pressure Meter (MicroRPM)In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all healthy adolescent. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- It was calculated that at least 36 patients in total, 18 patients in the scoliosis and healthy groups, should be included in the study.
Key inclusion criteria (3 listed)
- Individuals agreeing to participate in the study
- In the age range of 10-20
- Patients with scoliosis with a Cobb angle of 10-40 degrees measured on X-Ray
Key exclusion criteria (2 listed)
- Surgical operation in the last 3 months
- Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises.
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 |
|---|---|---|
| Respiratory Pressure Meter (MicroRPM)Also: Biodex Balance System®Peripheral muscle strength, respiratory muscle strength and postural controls of all adolescents will be evaluated. The values of the scoliotic and healthy groups will be compared. | Device | Healthy group, Scoliosis group |
Primary outcome
Respiratory Muscle Strength
Time frame: Baseline
Respiratory muscle strength will be made with a portable, electronic intraoral pressure measuring device.
Peripheral Muscle Strength
Time frame: Baseline
Peripheral muscle strength will be performed using an electronic dynamometer.
Postural Control
Time frame: Baseline
Postural Stability and Balance will be evaluated with the Biodex Balance System®.
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 7 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Adolescent Idiopathic Scoliosis
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Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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?
An observational study of Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif 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 3 inclusion and 2 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 7 Aug 2026. 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?
Respiratory Muscle Strength (time frame: Baseline). The study lists 3 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 7 Aug 2026.