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临床试验/NCT04297696
NCT04297696已完成不适用

Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.

Cukurova University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年1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
19
试验地点
2
主要终点
Haemophilia Joint Health Score

研究概览

简要总结

Arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. This situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. Disorders in these parameters are the main causes of gait dysfunction. The aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • To be diagnosed as Hemophilia A or Hemophilia B
  • To be over 18 years old
  • To have hemophilic arthropathy in at least one joint
  • Undergoing prophylaxis or factor VIII-IX replacement therapy

排除标准

  • Having another congenital coagulopathy, such as Von Willebrand syndrome
  • To be unable to walk due to hemophilic arthropathy
  • Having another musculoskeletal problem
  • Individuals with inhibitors against Factor VIII-IX

结局指标

主要结局

Haemophilia Joint Health Score

时间窗: Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months

Haemophilia Joint Health Score (HJHS) will be applied to evaluate the joint functions of hemophilic individuals. HJHS is a sensitive and valid test used to determine the severity of clinical symptoms that result from hemarthrosis. This comprises an assessment of joints with regards to swelling, muscle atrophy, crepitus, range of motion, joint pain, strength, and global gait. The score for each joint is summed to obtain a total score ranging from 0 to 124, where no joint damage is indicated by a score of 0.

Range of Motion Analysis with Kinovea Software

时间窗: Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.

Range of motion (ROM) analysis during gait will be done by analyzing video images with computer software "Kinovea". Kinovea is a free software used by sports and healthcare professionals to analyze video images during physical activity. Furthermore, it is a sensitive method that can be used to evaluate the range of motion of the lower limb joints during gait. ROM analysis of the ankle and knee joints will be done with Kinovea in the heel strike-midstance-toe off and mid-swing phases.

次要结局

  • Haemophilia Quality of Life Questionnaire for Adults(Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months)
  • Six Minutes Walking Test(Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months)

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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