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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
ICF-Based Functional Limitations Questionnaire Total Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Intensity by Visual Analog Scale (VAS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline assessment, single study visit
|
Measured using Bunnell scoliometer, reported in degrees.
|
Baseline assessment, single study visit
|
|
Thoracic Kyphosis Angle
Lasso di tempo: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
Lumbar Lordosis Angle
Lasso di tempo: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
SRS-22 Total Score
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Chest Expansion
Lasso di tempo: 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
Lasso di tempo: Baseline assessment, single study visit
|
Passive cervical rotation measured in degrees.
|
Baseline assessment, single study visit
|
|
Peripheral Joint Range of Motion
Lasso di tempo: Baseline assessment, single study visit
|
Shoulder, hip, knee, and ankle range of motion measured in degrees.
|
Baseline assessment, single study visit
|
|
Limb Length Discrepancy
Lasso di tempo: Baseline assessment, single study visit
|
Difference between lower limb lengths, reported in centimeters.
|
Baseline assessment, single study visit
|
|
Waist-to-Height Ratio (WHtR)
Lasso di tempo: Baseline assessment, single study visit
|
Calculated from waist circumference and height.
|
Baseline assessment, single study visit
|
|
Maximum Mouth Opening
Lasso di tempo: Baseline assessment, single study visit
|
Mandibular abduction measured in centimeters.
|
Baseline assessment, single study visit
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SKE.0030.4.2026
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .