跳至主要内容
临床试验/NCT05924581
NCT05924581招募中不适用

Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth

Istituto Scientifico Italiano Colonna Vertebrale2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Reliability

研究概览

简要总结

This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Scoliosis > 10°Cobb or Hyperkyophosis >50° Cobb
  • Age between 10 and 17 years old
  • Risser between 0 and 5

排除标准

  • History of spinal surgery
  • Presence of back pain
  • Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases

结局指标

主要结局

Reliability

时间窗: through study completion, an average of 6 months

Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated

Repeatability

时间窗: through study completion, an average of 6 months

Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests

Diagnostic accuracy

时间窗: through study completion, an average of 6 months

diagnostic sensitivity and specificity of each test

次要结局

未报告次要终点

研究者

发起方
Istituto Scientifico Italiano Colonna Vertebrale
申办方类型
Other
责任方
Sponsor

研究点 (2)

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