TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- TRACE2
研究概览
简要总结
Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale.
This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of scoliosis
- •age between 10 and 17 years old
- •scoliosis >10° Cobb
- •humps > 5° ATR
排除标准
- •History of spinal surgery
- •positive neurological assessment
结局指标
主要结局
TRACE2
时间窗: through study completion, an average of 1 year
New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis
次要结局
未报告次要终点