Acute Effects of Self-correcting Movement on the Balance and Spine of Patients With Scoliosis. Observational Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 主要终点
- Balance during self-elongation movement
研究概览
简要总结
The purpose of this study is to evaluate the acute effects of the self-elongation movement on the balance of patients (aged 8-16 years) suffering from adolescent idiopathic scoliosis,
详细描述
Recruitment will be carried out by the physician during the scheduled follow-up. The participant and both parents, or the legal guardian, will receive information on the purpose and methods of this study. The informed consent of both parents, or the legal guardian, and of the minor will be requested.
Balance data (oscillations, sway area) will be collected by letting participants get on a stabilometric platform and placing their feet on the landmarks; position will not change for the duration of the assessments.
At the same time, the modification of the amplitude of the scoliotic curves will be evaluated with the use of the Spine 3D (medical class system) which uses micro-pulse laser technology to make a three-dimensional reconstruction of the spine.
Three 10-seconds assessments will be made. In the first the subject will reproduce the position hold for the scheduled radiography and an acquisition will be performed with the Spine3D. The obtained image will be compared with the radiographic one to improve the accuracy of the next evaluations. During the last two acquisitions, the stabilometric platform and the 3D Spine will be used simultaneously and the data for the study will be collected. The second acquisition will be performed in a physiological position and the third in self-lengthening, a position used in most of the rehabilitation methods for scoliosis. The full evaluation will take approximately 15 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of idiopathic scoliosis, carried out by the Physician with the Adams test and the scoliometer;
- •age between 8 and 16 years, both sexes;
- •ability to perform the self-elongation movement;
- •amplitude of the major scoliotic curve <40 degrees Cobb;
- •scheduled annual follow-up which requires a radiograph.
排除标准
- •secondary scoliosis;
- •orthopedic pathologies that modify the plantar supports;
- •pathologies that modify balance (neurological and / or vestibular);
- •inability to understand and sign informed consent / assent.
结局指标
主要结局
Balance during self-elongation movement
时间窗: 15 minutes
To evaluate the acute effects of the self-elongation movement on the balance of patients with idiopathic scoliosis, mainly in the area of postural oscillations (oscillation area).
次要结局
- Size of the major curve(15 minutes)
- Number of patients who improve balance(15 minutes)