跳至主要内容
临床试验/NCT05377086
NCT05377086已完成不适用

Comparison of the Effectiveness of the Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease

Biruni University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Cobb angle

研究概览

简要总结

Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. The study included 50 patients with a spinal x-ray scoliosis problem, aged 8-16 years, who were diagnosed with rheumatism at least 6 months ago, whose medical treatment was stable, Risser 0-4 and exercise indication (Cobb = 10-45ͦ). Patients with additional neurological diagnosis against rheumatism, who have received any previous treatment for a spine problem, who have a mental state and who do not have the consent of their family will not be included. The cases will be divided into 2 groups by method. In the first group (n = 25), structured 3-dimensional scoliosis exercises are taught in the clinic, and the second group (n = 25) is taught conventional physiotherapy applications (posture-core applications-bennet protocols) in the clinic, and both groups are followed by the WTE method.

详细描述

The demographic and clinical characteristics of all subjects willing to participate in the study will be questioned with the "Sociodemographic Data Form". Sociodemographic data form; pain, age, gender, height, weight, type of rheumatism, how many years ago the patient was diagnosed, the presence of rheumatism and scoliosis in the family, the drugs used, exercise habits, exacerbation history, whether they used a device before, and the awareness of the family about scoliosis. The trunk rotation angles with the forward bend test and the Cobb angle with the SubrotoAngleAid application via x-ray. Respiratory functions will be evaluated with portable spirometer, body awareness will be evaluated with Walter Reed Visual Assessment Scale, and quality of life will be evaluated with Scoliosis Research Association Scale-22 (SRS-22). After the evaluations, in the first treatment session in the clinic, the cases in the first group; Body awareness, respiratory control, differences between rotational and normal breathing, posture exercises and core stabilization exercises will be taught and family training will be provided. In the next session, a home program will be created by applying 3D scoliosis exercises that are structured according to the needs of the patients. Body awareness, respiratory control, posture exercises and core stabilization exercises will be taught and family training will be given to the patients in the second group in the first treatment session. In the next session, conventional exercises for the needs of the cases will be taught and a home exercise program will be created. Both groups will be interviewed for 2-week periods using the WTE method, and the exercises will be progressed gradually as needed. At the beginning of the treatment and in the 6th month, all evaluations will be repeated and the effectiveness of the exercises will be investigated. SPSS (Statistical Package for Social Sciences) (SPSS 21.0) statistical program will be used in the statistical analysis of the data. In all statistical analyzes, p <0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cases with a diagnosis of rheumatism in whom scoliosis problems were detected by spine X-ray,
  • be between the ages of 8-16,
  • Being between 0-4 in the riser,
  • Being in exercise indication (Cobb=10-45 ˚)

排除标准

  • Having an additional neurological or orthopedic diagnosis other than scoliosis accompanying rheumatism and affecting treatment results
  • Having had any surgery on the spine
  • Have had previous scoliosis treatment poor mental state

结局指标

主要结局

Cobb angle

时间窗: 0-6 month

Measuring the scoliosis angle on x-ray is the most commonly used method. The Cobb angle is most commonly used to measure the magnitude of the curve. Measurements are made on a standing posteroanterior spine radiograph as standard. To determine the boundaries of the scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines are drawn parallel to these two lines and the angle between the two lines is measured. This angle is defined as the scoliosis angle (Cobb angle). Radiological imaging will only be applied to children who are considered to be in need by the doctor as a result of physical examination. The measurement of the Cobb angle will be made on the X-ray via the SubrotoAngleAid application.

Trunk rotation with Scoliometer

时间窗: 0-6 month

The trunk rotation angle will be measured with a scoliometer. It is an easy to use, reliable, practical and specially designed inclinometer in the clinical evaluation of scoliosis. It is accepted as a clinical evaluation method used in addition to radiological methods in determining the efficacy of treatment and the prognosis of scoliosis.

次要结局

  • PEF(0-6 month)
  • FEV1(0-6 month)
  • QUALITY OF LIFE ASSESSMENT(0-6 month)
  • Physical deformity assesment using with The Walter Reed Visual Assessment Scale (WRVAS)(0-6 month)
  • FVC(0-6 month)

研究者

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

Eylül Pınar KISA

Lecturer

Biruni University

研究点 (2)

Loading locations...

相似试验