- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07559539
Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline assessment, single study visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity by Visual Analog Scale (VAS)
Time Frame: Baseline assessment, single study visit
|
Pain severity assessed on a 0 to 10 scale.
Higher scores indicate greater pain intensity.
|
Baseline assessment, single study visit
|
|
Forced Vital Capacity (FVC % Predicted)
Time Frame: Baseline assessment, single study visit
|
Pulmonary function assessed by spirometry.
Higher values indicate better respiratory function.
|
Baseline assessment, single study visit
|
|
Forced Expiratory Volume in 1 Second (FEV1 % Predicted)
Time Frame: Baseline assessment, single study visit
|
Spirometry measure of expiratory volume in one second.
Higher values indicate better pulmonary function.
|
Baseline assessment, single study visit
|
|
Angle of Trunk Rotation
Time Frame: Baseline assessment, single study visit
|
Measured using Bunnell scoliometer, reported in degrees.
|
Baseline assessment, single study visit
|
|
Thoracic Kyphosis Angle
Time Frame: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
Lumbar Lordosis Angle
Time Frame: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
SRS-22 Total Score
Time Frame: Baseline assessment, single study visit
|
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.
|
Baseline assessment, single study visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest Expansion
Time Frame: Baseline assessment, single study visit
|
Difference between maximal inhalation and exhalation chest circumference, reported in centimeters.
|
Baseline assessment, single study visit
|
|
Cervical Rotation Range of Motion
Time Frame: Baseline assessment, single study visit
|
Passive cervical rotation measured in degrees.
|
Baseline assessment, single study visit
|
|
Peripheral Joint Range of Motion
Time Frame: Baseline assessment, single study visit
|
Shoulder, hip, knee, and ankle range of motion measured in degrees.
|
Baseline assessment, single study visit
|
|
Limb Length Discrepancy
Time Frame: Baseline assessment, single study visit
|
Difference between lower limb lengths, reported in centimeters.
|
Baseline assessment, single study visit
|
|
Waist-to-Height Ratio (WHtR)
Time Frame: Baseline assessment, single study visit
|
Calculated from waist circumference and height.
|
Baseline assessment, single study visit
|
|
Maximum Mouth Opening
Time Frame: Baseline assessment, single study visit
|
Mandibular abduction measured in centimeters.
|
Baseline assessment, single study visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKE.0030.4.2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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