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Not yet recruiting NCT07187271

Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

Observational Adolescent Idiopathic Scoliosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 12 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Respiratory Parameters, Aerobic Capacity, and Sleep Quality in Individuals With Thoracic Adolescent Idiopathic Scoliosis

Overview

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.

Detailed description

This study aims to compare respiratory parameters (including pulmonary function tests and respiratory muscle strength), aerobic capacity, and sleep quality in individuals aged 12 to 20 years with thoracic adolescent idiopathic scoliosis (AIS), classified as T-type or TL-type based on the ISST classification. The study will be conducted at the Spine Health Center of Acıbadem Maslak Hospital.

A total of 30 volunteer participants will be included. Sagittal plane curvatures will be assessed using EOS imaging, and Cobb angles and axial trunk rotation (ATR) will be recorded. ATR will be measured using a scoliometer during the Adams forward bend test. Demographic data including age, sex, height, weight, and dominant side will also be collected.

Pulmonary function will be assessed using FVC and FEV₁ measurements, while respiratory muscle strength will be evaluated using the Cosmed Pony Fx device to measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). Each test will be repeated three times, and the highest value will be used for analysis. Aerobic capacity will be evaluated using a progressive shuttle walk test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and body image perception will be evaluated using the Scoliosis Appearance Questionnaire.

This is a cross-sectional observational study. Data will be compared between the T-type and TL-type scoliosis groups. The study will be supported by Üsküdar University, and all required devices will be provided by the university.

Primary outcome measures

  • Respiratory Muscle Strength (MIP, MEP) [Time frame: At baseline (single measurement during study enrollment)]
Secondary outcome measures (4)
  • Pulmonary Function (FVC, FEV₁) [Time frame: At baseline (single measurement during study enrollment)]
  • Aerobic Capacity (Incremental Shuttle Walk Test, ISWT) [Time frame: At baseline (single measurement during study enrollment)]
  • Sleep Quality (PUKI - Pittsburgh Sleep Quality Index) [Time frame: At baseline (single measurement during study enrollment)]
  • Body Image (Scoliosis Appearance Questionnaire, SAQ) [Time frame: At baseline (self-administered questionnaire during study enrollment)]

Eligibility criteria

Inclusion criteria

Individuals with a Cobb angle greater than 10 degrees Adolescents aged 12-20 years diagnosed with thoracic Adolescent Idiopathic Scoliosis, classified as T-type or TL-type according to ISST classification Patients currently undergoing brace treatment

Exclusion criteria

Individuals with a history of spinal surgery Individuals with neurological disorders Individuals with a diagnosed psychiatric disorder Pregnant individuals Individuals who do not provide consent to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Acıbadem Hospital — Istanbul

Identifiers

NCT: NCT07187271 · 2025-PT-GIZEM-AIS · 61351342/020-774 · 2025-05/36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗