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临床试验/NCT07187271
NCT07187271尚未招募不适用

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

Uskudar University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Respiratory Muscle Strength (MIP, MEP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Respiratory Muscle Strength (MIP, MEP)

时间窗: At baseline (single measurement during study enrollment)

Respiratory muscle strength will be assessed using an electronic mouth pressure meter (Cosmed Pony FX, ) by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). This outcome evaluates the strength of inspiratory and expiratory muscles in participants with thoracic and thoracolumbar AIS.

次要结局

  • Pulmonary Function (FVC, FEV₁)(At baseline (single measurement during study enrollment))
  • Aerobic Capacity (Incremental Shuttle Walk Test, ISWT)(At baseline (single measurement during study enrollment))
  • Sleep Quality (PUKI - Pittsburgh Sleep Quality Index)(At baseline (single measurement during study enrollment))
  • Body Image (Scoliosis Appearance Questionnaire, SAQ)(At baseline (self-administered questionnaire during study enrollment))

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Sevindi

Physiotherapist

Uskudar University

研究点 (1)

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