Adolescence Idiopathic ScoliosisAISNCT07559539
Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis
An observational study of Adolescence Idiopathic Scoliosis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Adolescence Idiopathic Scoliosis
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 16 May 2026to 16 Aug 2028
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Polish patients
Who may be able to join
- Female, age 25-40
- AIS diagnosed before age 18 (Cobb angle >35°)
- Operated group: PSF, 10-25 years post-surgery
- Informed consent
Who cannot join
- Surgery other than PSF
- Surgery performed in adulthood
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Akademia Wychowania Fizycznego Józefa Piłsudskiego w Warszawie
Warsaw, Masovian Voivodeship, 05-119
Joanna Gawrylczyk, +48 792430508, jg710@stud.awf.edu.pl
About this study
Official title: Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis With Comparison to Non-Operatively Treated and Non-Scoliotic Individuals
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood.
This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires.
The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a structural spinal deformity associated with long-term alterations in musculoskeletal function, posture, and respiratory mechanics. In progressive cases, surgical correction using posterior spinal fusion (PSF) is performed during adolescence; however, long-term functional outcomes remain insufficiently characterized.
This observational, cross-sectional study compares adults with surgically treated AIS, conservatively treated AIS, and healthy controls. Participants will undergo a standardized assessment protocol including anthropometric measurements, clinical examination, and patient-reported outcomes.
Anthropometric assessment will include body height, sitting height, body mass, arm span, waist and hip circumference, lower limb length and asymmetry, and chest circumference at rest and maximal inspiration, with derived indices of body proportions.
Functional status will be assessed using an author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), capturing perceived limitations in body functions, activities, participation, and environmental factors.
Clinical evaluation will include assessment of spinal curvature and pelvic alignment using inclinometric and scoliometric methods, as well as range of motion (ROM) of the cervical spine, temporomandibular joint, and peripheral joints. Additional orthopedic functional tests will be performed to assess lumbopelvic and lower limb function.
Pain will be evaluated using validated scales and graphical mapping of pain distribution.
Respiratory assessment will include spirometry and flow-volume measurements conducted according to international standards, chest wall mobility assessment, and measurement of respiratory muscle strength (maximal inspiratory and expiratory pressures). In addition, diaphragm structure and function will be evaluated using ultrasound imaging. Measurements will include diaphragm thickness and thickening fraction during respiratory cycles, as well as diaphragmatic excursion during quiet and deep breathing, performed under standardized conditions. This assessment aims to provide an objective evaluation of diaphragmatic mechanics, which may be altered in individuals with thoracic deformity or after surgical stabilization of the spine.
Exploratory analyses will examine associations between clinical variables and functional outcomes. The study aims to provide a comprehensive characterization of long-term functional status and inform targeted rehabilitation strategies.
- Conditions
- Adolescence Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, adult scoliosis, spinal fusion, Long-Term Adverse Effects
- Medical subject headings
- Scoliosis, Long Term Adverse Effects
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF-Based Functional Limitations Questionnaire Total Score
Author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), assessing body functions, activities, participation, and environmental factors. Higher total scores indicate greater disability.
Measured: Baseline assessment, single study visit
Secondary outcomes (7)
SRS-22 Total Score
Quality of life assessed using the Scoliosis Research Society-22 questionnaire. The questionnaire contains 22 items across five domains (function/activity, pain, self-image/appearance, mental health, and satisfaction with management), each scored from 1 to 5. Mean domain scores and the total mean score range from 1 to 5, with higher scores indicating better function and higher quality of life.
Measured: Baseline assessment, single study visit
Pain Intensity by Visual Analog Scale (VAS)
Pain severity assessed on a 0 to 10 scale. Higher scores indicate greater pain intensity.
Measured: Baseline assessment, single study visit
Forced Vital Capacity (FVC % Predicted)
Pulmonary function assessed by spirometry. Higher values indicate better respiratory function.
Measured: Baseline assessment, single study visit
Forced Expiratory Volume in 1 Second (FEV1 % Predicted)
Spirometry measure of expiratory volume in one second. Higher values indicate better pulmonary function.
Measured: Baseline assessment, single study visit
Angle of Trunk Rotation
Measured using Bunnell scoliometer, reported in degrees.
Measured: Baseline assessment, single study visit
Thoracic Kyphosis Angle
Measured using inclinometer/plurimeter, reported in degrees.
Measured: Baseline assessment, single study visit
Lumbar Lordosis Angle
Measured using inclinometer/plurimeter, reported in degrees.
Measured: Baseline assessment, single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start16 May 2026
- Primary completion16 Aug 2028 (estimated)
- Study completion16 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescence 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559539
- Sponsor's protocol ID
- SKE.0030.4.2026
- Acronym
- AIS
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis With Comparison to Non-Operatively Treated and Non-Scoliotic Individuals
- ClinicalTrials.gov ID
- NCT07559539
- Acronym / sponsor ID
- AIS / SKE.0030.4.2026
- Conditions
- Adolescence Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, adult scoliosis, spinal fusion, Long-Term Adverse Effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 16 Aug 2028 (estimated)
- Study completion
- 16 Aug 2028 (estimated)
- First posted
- 30 Apr 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 three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood.
This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires.
The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a structural spinal deformity associated with long-term alterations in musculoskeletal function, posture, and respiratory mechanics. In progressive cases, surgical correction using posterior spinal fusion (PSF) is performed during adolescence; however, long-term functional outcomes remain insufficiently characterized.
This observational, cross-sectional study compares adults with surgically treated AIS, conservatively treated AIS, and healthy controls. Participants will undergo a standardized assessment protocol including anthropometric measurements, clinical examination, and patient-reported outcomes.
Anthropometric assessment will include body height, sitting height, body mass, arm span, waist and hip circumference, lower limb length and asymmetry, and chest circumference at rest and maximal inspiration, with derived indices of body proportions.
Functional status will be assessed using an author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), capturing perceived limitations in body functions, activities, participation, and environmental factors.
Clinical evaluation will include assessment of spinal curvature and pelvic alignment using inclinometric and scoliometric methods, as well as range of motion (ROM) of the cervical spine, temporomandibular joint, and peripheral joints. Additional orthopedic functional tests will be performed to assess lumbopelvic and lower limb function.
Pain will be evaluated using validated scales and graphical mapping of pain distribution.
Respiratory assessment will include spirometry and flow-volume measurements conducted according to international standards, chest wall mobility assessment, and measurement of respiratory muscle strength (maximal inspiratory and expiratory pressures). In addition, diaphragm structure and function will be evaluated using ultrasound imaging. Measurements will include diaphragm thickness and thickening fraction during respiratory cycles, as well as diaphragmatic excursion during quiet and deep breathing, performed under standardized conditions. This assessment aims to provide an objective evaluation of diaphragmatic mechanics, which may be altered in individuals with thoracic deformity or after surgical stabilization of the spine.
Exploratory analyses will examine associations between clinical variables and functional outcomes. The study aims to provide a comprehensive characterization of long-term functional status and inform targeted rehabilitation strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Polish patients
Key inclusion criteria (4 listed)
- Female, age 25-40
- AIS diagnosed before age 18 (Cobb angle >35°)
- Operated group: PSF, 10-25 years post-surgery
- Informed consent
Key exclusion criteria (2 listed)
- Surgery other than PSF
- Surgery performed in adulthood
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
ICF-Based Functional Limitations Questionnaire Total Score
Time frame: Baseline assessment, single study visit
Author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), assessing body functions, activities, participation, and environmental factors. Higher total scores indicate greater disability.
7 secondary outcomes
SRS-22 Total Score
Time frame: Baseline assessment, single study visit
Pain Intensity by Visual Analog Scale (VAS)
Time frame: Baseline assessment, single study visit
Forced Vital Capacity (FVC % Predicted)
Time frame: Baseline assessment, single study visit
Forced Expiratory Volume in 1 Second (FEV1 % Predicted)
Time frame: Baseline assessment, single study visit
Angle of Trunk Rotation
Time frame: Baseline assessment, single study visit
Thoracic Kyphosis Angle
Time frame: Baseline assessment, single study visit
Lumbar Lordosis Angle
Time frame: Baseline assessment, single study visit
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 6 Aug 2026.
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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.
Akademia Wychowania Fizycznego Józefa Piłsudskiego w Warszawie
Warsaw, Poland
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 Adolescence Idiopathic Scoliosis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 4 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: looking for participants now, as of the sponsor's last update on 6 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF-Based Functional Limitations Questionnaire Total Score (time frame: Baseline assessment, single study visit). 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 6 Aug 2026.