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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.

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

90

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 05-119
        • Rekruttering
        • Akademia Wychowania Fizycznego Józefa Piłsudskiego w Warszawie
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Polish patients

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ICF-Based Functional Limitations Questionnaire Total Score
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

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

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. mai 2026

Primær fullføring (Antatt)

16. august 2028

Studiet fullført (Antatt)

16. august 2028

Datoer for studieregistrering

Først innsendt

27. mars 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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