- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polônia, 05-119
- Recrutamento
- Akademia Wychowania Fizycznego Józefa Piłsudskiego w Warszawie
-
Contato:
- Joanna Gawrylczyk
- Número de telefone: +48 792430508
- E-mail: jg710@stud.awf.edu.pl
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
ICF-Based Functional Limitations Questionnaire Total Score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity by Visual Analog Scale (VAS)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: Baseline assessment, single study visit
|
Measured using Bunnell scoliometer, reported in degrees.
|
Baseline assessment, single study visit
|
|
Thoracic Kyphosis Angle
Prazo: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
Lumbar Lordosis Angle
Prazo: Baseline assessment, single study visit
|
Measured using inclinometer/plurimeter, reported in degrees.
|
Baseline assessment, single study visit
|
|
SRS-22 Total Score
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Chest Expansion
Prazo: 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
Prazo: Baseline assessment, single study visit
|
Passive cervical rotation measured in degrees.
|
Baseline assessment, single study visit
|
|
Peripheral Joint Range of Motion
Prazo: Baseline assessment, single study visit
|
Shoulder, hip, knee, and ankle range of motion measured in degrees.
|
Baseline assessment, single study visit
|
|
Limb Length Discrepancy
Prazo: Baseline assessment, single study visit
|
Difference between lower limb lengths, reported in centimeters.
|
Baseline assessment, single study visit
|
|
Waist-to-Height Ratio (WHtR)
Prazo: Baseline assessment, single study visit
|
Calculated from waist circumference and height.
|
Baseline assessment, single study visit
|
|
Maximum Mouth Opening
Prazo: Baseline assessment, single study visit
|
Mandibular abduction measured in centimeters.
|
Baseline assessment, single study visit
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SKE.0030.4.2026
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .