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临床试验/NCT06021314
NCT06021314已完成不适用

Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis

Baskent University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Change of in-brace scoliosis angle

研究概览

简要总结

The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.

The main questions it aims to answer are:

  • Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces?
  • Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
  • Having a standing posterior-anterior radiograph before and during the brace use.
  • Having a curve of 20 degree and above according to the Cobb angle.
  • Confirmation of participation.

排除标准

  • Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).

结局指标

主要结局

Change of in-brace scoliosis angle

时间窗: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

"Cobb angle" will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated. In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.

Generalised Joint Hypermobility

时间窗: After participant being included in the study, latest at the 4th week of the brace use.

A nine-degree "Beighton scale" will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.

次要结局

  • Change of in-brace global cronal balance(Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use)
  • Change of in-brace vertebral rotation(Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use)
  • Change of in-brace spinal height(Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use)
  • Change of in-brace apical translation(Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use)
  • Brace compliance(in-brace condition at the 4th week of the brace use)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Senay Cerezci Duygu

Asst. Prof.

Saglik Bilimleri Universitesi

研究点 (1)

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