Adolescent Idiopathic ScoliosisNCT07187271
Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS
An observational study of Adolescent Idiopathic Scoliosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent patients aged 12-20 years with thoracic or thoracolumbar Adolescent Idiopathic Scoliosis recruited from Acıbadem Maslak Hospital Spine Health Center.
Who may be able to join
- Individuals with a Cobb angle greater than 10 degrees Adolescents aged 12-20 years diagnosed with thoracic Adolescent Idiopathic Scoliosis, classified as T-type or TL-type according to ISST classification Patients currently undergoing brace treatment
Who cannot join
- Individuals with a history of spinal surgery Individuals with neurological disorders Individuals with a diagnosed psychiatric disorder Pregnant individuals Individuals who do not provide consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Acıbadem Hospital
Istanbul, Europe & Central Asia - Upper Middle Income, 34396
Gizem Sevindi, PT., +905388569613, gizemsevindi.fzt@gmail.com
Filiz Eyüboğlu, PhD.
About this study
Official title: Comparison of Respiratory Parameters, Aerobic Capacity, and Sleep Quality in Individuals With Thoracic Adolescent Idiopathic Scoliosis
This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.
Read the detailed description
This study aims to compare respiratory parameters (including pulmonary function tests and respiratory muscle strength), aerobic capacity, and sleep quality in individuals aged 12 to 20 years with thoracic adolescent idiopathic scoliosis (AIS), classified as T-type or TL-type based on the ISST classification. The study will be conducted at the Spine Health Center of Acıbadem Maslak Hospital.
A total of 30 volunteer participants will be included. Sagittal plane curvatures will be assessed using EOS imaging, and Cobb angles and axial trunk rotation (ATR) will be recorded. ATR will be measured using a scoliometer during the Adams forward bend test. Demographic data including age, sex, height, weight, and dominant side will also be collected.
Pulmonary function will be assessed using FVC and FEV₁ measurements, while respiratory muscle strength will be evaluated using the Cosmed Pony Fx device to measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Each test will be repeated three times, and the highest value will be used for analysis. Aerobic capacity will be evaluated using a progressive shuttle walk test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and body image perception will be evaluated using the Scoliosis Appearance Questionnaire.
This is a cross-sectional observational study. Data will be compared between the T-type and TL-type scoliosis groups. The study will be supported by Üsküdar University, and all required devices will be provided by the university.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS, ISST classification, Thoracic AIS, Thoracolumbar AIS, Cobb angle, Angle of Trunk Rotation (ATR), Pulmonary function test, FEV1, FVC, Respiratory muscle strength, MIP (Maximal Inspiratory Pressure), MEP (Maximal Expiratory Pressure), Aerobic capacity, Incremental Shuttle Walk Test (ISWT), PUKİ (Pittsburgh Sleep Quality Index), SAQ (Scoliosis Appearance Questionnaire)
- Medical subject headings
- Laurin-Sandrow syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T-Type | Participants diagnosed with thoracic type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracic curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group. | |
| TL-Type | Participants diagnosed with thoracolumbar type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracolumbar curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength (MIP, MEP)
Respiratory muscle strength will be assessed using an electronic mouth pressure meter (Cosmed Pony FX, ) by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This outcome evaluates the strength of inspiratory and expiratory muscles in participants with thoracic and thoracolumbar AIS.
Measured: At baseline (single measurement during study enrollment)
Secondary outcomes (4)
Pulmonary Function (FVC, FEV₁)
Pulmonary function will be assessed using an electronic spirometry device (Cosmed Pony FX, ) by measuring Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁). This outcome evaluates respiratory capacity in participants with thoracic and thoracolumbar AIS.
Measured: At baseline (single measurement during study enrollment)
Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)
Aerobic capacity will be measured using the Incremental Shuttle Walk Test (ISWT) to determine exercise tolerance and endurance in participants with thoracic and thoracolumbar AIS.
Measured: At baseline (single measurement during study enrollment)
Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)
Sleep quality will be evaluated with the validated Turkish version of the Pittsburgh Sleep Quality Index (PUKI). Higher scores indicate poorer sleep quality.
Measured: At baseline (single measurement during study enrollment)
Body Image (Scoliosis Appearance Questionnaire, SAQ)
Body image perception will be assessed with the Scoliosis Appearance Questionnaire (SAQ) to evaluate patients' perception of spinal deformity.
Measured: At baseline (self-administered questionnaire during study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start5 Oct 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
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.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Sevindi, Uskudar University
- Investigators
- Filiz Eyüboğlu, PhD., Study director, Uskudar UniversityMert İlhan, MSc., Principal investigator, Uskudar UniversityGizem Sevindi, PT., Principal investigator, Uskudar UniversityÇağlar Yılgör, Prof., Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187271
- Sponsor's protocol ID
- 2025-PT-GIZEM-AIS
- Other IDs
- 61351342/020-774, 2025-05/36
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory Parameters, Aerobic Capacity, and Sleep Quality in Individuals With Thoracic Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07187271
- Acronym / sponsor ID
- 2025-PT-GIZEM-AIS
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS, ISST classification, Thoracic AIS, Thoracolumbar AIS, Cobb angle, Angle of Trunk Rotation (ATR), Pulmonary function test, FEV1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 22 Sep 2025 (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.
This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.
Detailed description
This study aims to compare respiratory parameters (including pulmonary function tests and respiratory muscle strength), aerobic capacity, and sleep quality in individuals aged 12 to 20 years with thoracic adolescent idiopathic scoliosis (AIS), classified as T-type or TL-type based on the ISST classification. The study will be conducted at the Spine Health Center of Acıbadem Maslak Hospital.
A total of 30 volunteer participants will be included. Sagittal plane curvatures will be assessed using EOS imaging, and Cobb angles and axial trunk rotation (ATR) will be recorded. ATR will be measured using a scoliometer during the Adams forward bend test. Demographic data including age, sex, height, weight, and dominant side will also be collected.
Pulmonary function will be assessed using FVC and FEV₁ measurements, while respiratory muscle strength will be evaluated using the Cosmed Pony Fx device to measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Each test will be repeated three times, and the highest value will be used for analysis. Aerobic capacity will be evaluated using a progressive shuttle walk test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and body image perception will be evaluated using the Scoliosis Appearance Questionnaire.
This is a cross-sectional observational study. Data will be compared between the T-type and TL-type scoliosis groups. The study will be supported by Üsküdar University, and all required devices will be provided by the university.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-Type | – | –Participants diagnosed with thoracic type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracic curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group. |
| TL-Type | – | –Participants diagnosed with thoracolumbar type Adolescent Idiopathic Scoliosis (AIS), defined as a primary thoracolumbar curve according to ISST classification. Eligible individuals are between 12 and 20 years of age and meet the inclusion criteria. All outcome measures, including pulmonary function tests, respiratory muscle strength, aerobic capacity, sleep quality, and body image assessments, will be evaluated in this group. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent patients aged 12-20 years with thoracic or thoracolumbar Adolescent Idiopathic Scoliosis recruited from Acıbadem Maslak Hospital Spine Health Center.
Key inclusion criteria (1 listed)
- Individuals with a Cobb angle greater than 10 degrees Adolescents aged 12-20 years diagnosed with thoracic Adolescent Idiopathic Scoliosis, classified as T-type or TL-type according to ISST classification Patients currently undergoing brace treatment
Key exclusion criteria (1 listed)
- Individuals with a history of spinal surgery Individuals with neurological disorders Individuals with a diagnosed psychiatric disorder Pregnant individuals Individuals who do not provide consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Muscle Strength (MIP, MEP)
Time frame: At baseline (single measurement during study enrollment)
Respiratory muscle strength will be assessed using an electronic mouth pressure meter (Cosmed Pony FX, ) by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This outcome evaluates the strength of inspiratory and expiratory muscles in participants with thoracic and thoracolumbar AIS.
4 secondary outcomes
Pulmonary Function (FVC, FEV₁)
Time frame: At baseline (single measurement during study enrollment)
Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)
Time frame: At baseline (single measurement during study enrollment)
Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)
Time frame: At baseline (single measurement during study enrollment)
Body Image (Scoliosis Appearance Questionnaire, SAQ)
Time frame: At baseline (self-administered questionnaire during study enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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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.
Filiz Eyüboğlu, PhD. study director
Uskudar University
Mert İlhan, MSc. principal investigator
Uskudar University
Gizem Sevindi, PT. principal investigator
Uskudar University
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 Uskudar 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 1 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: opening soon, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Sevindi, PT. (+905388569613, gizemsevindi.fzt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (MIP, MEP) (time frame: At baseline (single measurement during study enrollment)). 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 Sep 2025.