ScoliosisNCT07863492
The Effect of Curve Type Determined According to the Rigo Classification on Respiratory Muscle Strength, Quality of Life, and Functional Status in Individuals Diagnosed With Adolescent Idiopathic Scoliosis.
An observational study of Scoliosis and Respiratory Function, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is a disorder that occurs between the ages of 10 and 18, with an unknown etiology, and is characterized by a three-dimensional deformity of the spine. It is often asymptomatic at onset but may progressively lead to cosmetic and functional impairments over time. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis, Respiratory Function, Rigo Classification
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to Feb 2027
- 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 18 years
- All sexes
- Child, Adult
Study population: A total of 96 patients diagnosed with scoliosis who meet the study criteria and 24 healthy individuals will be selected from among those admitted to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Istanbul Physical Therapy and Rehabilitation Training and Research Hospital SUAM.
Who may be able to join
- Individuals with a Cobb angle greater than 10° and less than 60° (scoliosis group) Volunteers with a trunk rotation angle (ATR) of less than 5° measured by scoliometer and a negative Adam's test (control group) Aged between 12 and 18 years No history of surgical intervention due to scoliosis Ability to understand and respond to questions Literate individuals Individuals who provide informed consent themselves and whose families also give consent to participate in the study
Who cannot join
- Individuals under 12 years of age and over 18 years of age Individuals with conditions that hinder communication (hearing or speech impairments, accompanying intellectual disabilities, or inability to cooperate) Individuals with neurological, muscular, or rheumatologic diseases, or a history of previous spinal surgery Individuals who are not literate Individuals who do not volunteer to participate
About this study
Official title: The Effect of Curve Type Determined According to the Rigo Classification on Respiratory Muscle Strength, Quality of Life, and Functional Status in Individuals Diagnosed With Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS) is a disorder that occurs between the ages of 10 and 18, with an unknown etiology, and is characterized by a three-dimensional deformity of the spine. It is often asymptomatic at onset but may progressively lead to cosmetic and functional impairments over time. The Rigo classification, which evaluates the structural characteristics of scoliosis, is a three-dimensional functional classification system that takes into account the direction of the curve and the involved spinal regions
In studies conducted on individuals with AIS, a significant reduction in respiratory muscle strength (MIP-Maximum Inspiratory Pressure and MEP-Maximum Expiratory Pressure) has been observed, and this condition has been associated with thoracic rigidity and decreased physical activity . In individuals with AIS, a significant negative correlation has been reported between Cobb angle and FVC and FEV₁ values, as well as a moderate negative correlation between trunk rotation angle (ATR) and respiratory muscle strength (MIP and MEP). In light of these findings, it has been shown that as the severity of scoliosis increases, lung volumes decrease, and that scoliosis may affect respiration not only through a two-dimensional curvature angle but also through three-dimensional structural changes such as trunk rotation. Curves concentrated in the thoracic region according to the Rigo classification demonstrate more pronounced reductions in MIP and MEP values
The impact of AIS on quality of life has been evaluated, and it has been reported that individuals with AIS score lower than healthy individuals in domains such as body image, pain, mental health, and function
- Conditions
- Scoliosis, Respiratory Function, Rigo Classification, MIP, MEP
- Medical subject headings
- Scoliosis, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
MIP,MEP,"Curve type according to the Rigo classification"
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Sep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863492
- Sponsor's protocol ID
- 2026-28
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Curve Type Determined According to the Rigo Classification on Respiratory Muscle Strength, Quality of Life, and Functional Status in Individuals Diagnosed With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07863492
- Acronym / sponsor ID
- 2026-28
- Conditions
- Scoliosis, Respiratory Function, Rigo Classification, MIP, MEP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
Adolescent Idiopathic Scoliosis (AIS) is a disorder that occurs between the ages of 10 and 18, with an unknown etiology, and is characterized by a three-dimensional deformity of the spine. It is often asymptomatic at onset but may progressively lead to cosmetic and functional impairments over time. The Rigo classification, which evaluates the structural characteristics of scoliosis, is a three-dimensional functional classification system that takes into account the direction of the curve and the involved spinal regions
In studies conducted on individuals with AIS, a significant reduction in respiratory muscle strength (MIP-Maximum Inspiratory Pressure and MEP-Maximum Expiratory Pressure) has been observed, and this condition has been associated with thoracic rigidity and decreased physical activity . In individuals with AIS, a significant negative correlation has been reported between Cobb angle and FVC and FEV₁ values, as well as a moderate negative correlation between trunk rotation angle (ATR) and respiratory muscle strength (MIP and MEP). In light of these findings, it has been shown that as the severity of scoliosis increases, lung volumes decrease, and that scoliosis may affect respiration not only through a two-dimensional curvature angle but also through three-dimensional structural changes such as trunk rotation. Curves concentrated in the thoracic region according to the Rigo classification demonstrate more pronounced reductions in MIP and MEP values
The impact of AIS on quality of life has been evaluated, and it has been reported that individuals with AIS score lower than healthy individuals in domains such as body image, pain, mental health, and function
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 96 patients diagnosed with scoliosis who meet the study criteria and 24 healthy individuals will be selected from among those admitted to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Istanbul Physical Therapy and Rehabilitation Training and Research Hospital SUAM.
Key inclusion criteria (1 listed)
- Individuals with a Cobb angle greater than 10° and less than 60° (scoliosis group) Volunteers with a trunk rotation angle (ATR) of less than 5° measured by scoliometer and a negative Adam's test (control group) Aged between 12 and 18 years No history of surgical intervention due to scoliosis Ability to understand and respond to questions Literate individuals Individuals who provide informed consent themselves and whose families also give consent to participate in the study
Key exclusion criteria (1 listed)
- Individuals under 12 years of age and over 18 years of age Individuals with conditions that hinder communication (hearing or speech impairments, accompanying intellectual disabilities, or inability to cooperate) Individuals with neurological, muscular, or rheumatologic diseases, or a history of previous spinal surgery Individuals who are not literate Individuals who do not volunteer to participate
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
MIP,MEP,"Curve type according to the Rigo classification"
Time frame: 6 Month
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 7 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Respiratory Function, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
MIP,MEP,"Curve type according to the Rigo classification" (time frame: 6 Month). 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 Oct 2026.