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Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07559539
Acronym
AIS
Enrollment
90
Registered
2026-04-30
Start date
2026-05-16
Completion date
2028-08-16
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescence Idiopathic Scoliosis

Keywords

Adolescent Idiopathic Scoliosis, adult scoliosis, spinal fusion, Long-Term Adverse Effects

Brief 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). 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.

Interventions

None listed

Sponsors

Józef Piłsudski University of Physical Education
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Female, age 25-40 * AIS diagnosed before age 18 (Cobb angle \>35°) * Operated group: PSF, 10-25 years post-surgery * Informed consent

Exclusion criteria

* Surgery other than PSF * Surgery performed in adulthood

Design outcomes

Primary

MeasureTime frameDescription
ICF-Based Functional Limitations Questionnaire Total ScoreBaseline assessment, single study visitAuthor-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.

Secondary

MeasureTime frameDescription
SRS-22 Total ScoreBaseline assessment, single study visitQuality 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.
Pain Intensity by Visual Analog Scale (VAS)Baseline assessment, single study visitPain severity assessed on a 0 to 10 scale. Higher scores indicate greater pain intensity.
Forced Vital Capacity (FVC % Predicted)Baseline assessment, single study visitPulmonary function assessed by spirometry. Higher values indicate better respiratory function.
Forced Expiratory Volume in 1 Second (FEV1 % Predicted)Baseline assessment, single study visitSpirometry measure of expiratory volume in one second. Higher values indicate better pulmonary function.
Angle of Trunk RotationBaseline assessment, single study visitMeasured using Bunnell scoliometer, reported in degrees.
Thoracic Kyphosis AngleBaseline assessment, single study visitMeasured using inclinometer/plurimeter, reported in degrees.
Lumbar Lordosis AngleBaseline assessment, single study visitMeasured using inclinometer/plurimeter, reported in degrees.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026