Multidisciplinary Assessment of the Physical, Functional and Psychosocial Alterations in Patients With Hemophilia. An Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Assess the Joint Damage
研究概览
简要总结
Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:
- Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis.
- Descriptive study of the alterations of periarticular muscle strength as a result of acute processes or the development of chronic articular sequelae.
- Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.
- Descriptive study of the joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography.
- Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.
详细描述
Observational study that will allow us:
Analyze and evaluate the skeletal muscle of patients with hemophilia involvement.
Describe the periarticular muscular deficit, depending on the degree of injury, age, presence of inhibitors and the development of physical activity.
Identify the relationship between the functional deficit by clinical assessment performed with the use of validated scales measure force production with patients.
Observe the presence of joint bleeds in children with hemophilia and synovial hypertrophy developing therein.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 60 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with hemophilia A and B.
- •Patients of all ages (pediatric, adolescents, youth and adults).
- •With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint loading.
- •Patients with or without inhibitors.
排除标准
- •Patients without prior walking capacity.
- •Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- •Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
结局指标
主要结局
Assess the Joint Damage
时间窗: Screening visit
Measurement with Haemophilia Joint Health Score 2.1 (HJHS)
Assess the Perception of Quality of Life
时间窗: Screening visit
Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).
次要结局
- Measure of Weight(Screening visit (pretreatment assessment))
- Assessment of Clinical Patient Variables(Screening visit)
研究者
ANA TORRES-ORTUÑO
PhD
Universidad de Murcia