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临床试验/NCT05173129
NCT05173129已完成不适用

Comparison of Posture and Muscle Stiffness of Adolescent Boys With Haemophilia and Those of Age-matched Healthy Peers: a Controlled Cross-sectional Study

Cukurova University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年9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
44
试验地点
2
主要终点
Photogrammetry

研究概览

简要总结

Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. Joints are mechanical systems with a structure strictly related to functioning. Therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.The primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to determine the effect of joint dysfunction on posture in adolescent PwH.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).

排除标准

  • To be with another congenital coagulopathy such as von Willebrand syndrome.
  • To be unable to stand without support due to hemophilic arthropathy.
  • To be having another musculoskeletal problem.
  • To be having factor VIII or IX level in the plasma above 6%

结局指标

主要结局

Photogrammetry

时间窗: Baseline

The photogrammetry is a single evaluation method based on the analysis of two-dimensional photographs with a software.The erect-static posture of the participants will be analyzed with photogrammetry method. Firstly, two-dimensional photographs of the participant in the static-erect position will be taken.Afterwards, spinal and extremity angles will be measured in degrees using Kinovea™ software in the two-dimensional photographs transferred to the computer.

Myotonometric assessment

时间窗: Baseline

Myotonometric assessment is a reliable method in which the stiffness, elasticity and tone of the muscles are evaluated with a single measurement method.The mechanical properties (tone, stiffness, and elasticity) of the superficial muscles that affect posture will be evaluated with Myoton Pro™ device (Myoton AS, Tallinn, Estonia). With a single measurement made with Myoton Pro™ device, numerical values reflecting the mechanical properties of the muscle are obtained on the screen of the device.

次要结局

  • Haemophilia Joint Health Score(Baseline)

研究者

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

Volkan Deniz, PT

Director

Cukurova University

研究点 (2)

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