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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.

Studienübersicht

Status

Noch keine Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

90

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Polish patients

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ICF-Based Functional Limitations Questionnaire Total Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Intensity by Visual Analog Scale (VAS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline assessment, single study visit
Measured using Bunnell scoliometer, reported in degrees.
Baseline assessment, single study visit
Thoracic Kyphosis Angle
Zeitfenster: Baseline assessment, single study visit
Measured using inclinometer/plurimeter, reported in degrees.
Baseline assessment, single study visit
Lumbar Lordosis Angle
Zeitfenster: Baseline assessment, single study visit
Measured using inclinometer/plurimeter, reported in degrees.
Baseline assessment, single study visit
SRS-22 Total Score
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Chest Expansion
Zeitfenster: 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
Zeitfenster: Baseline assessment, single study visit
Passive cervical rotation measured in degrees.
Baseline assessment, single study visit
Peripheral Joint Range of Motion
Zeitfenster: Baseline assessment, single study visit
Shoulder, hip, knee, and ankle range of motion measured in degrees.
Baseline assessment, single study visit
Limb Length Discrepancy
Zeitfenster: Baseline assessment, single study visit
Difference between lower limb lengths, reported in centimeters.
Baseline assessment, single study visit
Waist-to-Height Ratio (WHtR)
Zeitfenster: Baseline assessment, single study visit
Calculated from waist circumference and height.
Baseline assessment, single study visit
Maximum Mouth Opening
Zeitfenster: Baseline assessment, single study visit
Mandibular abduction measured in centimeters.
Baseline assessment, single study visit

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

16. Mai 2026

Primärer Abschluss (Geschätzt)

16. August 2028

Studienabschluss (Geschätzt)

16. August 2028

Studienanmeldedaten

Zuerst eingereicht

27. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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