Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of range of motion of elbow, knee and ankle
研究概览
简要总结
Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain, El Salvador and Bolivia; describe deficit mobility and muscular strength, 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 measurement scales, the assessment of the degree of injury to specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their impact on gait in patients with hemophilia; and evaluate the factors that influence the perception of illness and quality of life of patients with hemophilia.
详细描述
Descriptive study of joint involvement in patients with hemophilia Spain, El Salvador and Bolivia.
Descriptive study of abnormal joint mobility and muscle strength as a result of acute conditions 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 overall articular involvement (crepitus, pain, biomechanical and functional changes) in patients with hemophilia.
Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perception of it, and their quality of life.
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
- 6 Years 至 65 Years（Child, Adult, Older 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 load legs.
- •Patients with or without inhibitors.
排除标准
- •Patients without prior ambulation 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
Assessment of range of motion of elbow, knee and ankle
时间窗: Screening visit
We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia
Assessment of muscle strength of arm, thigh and leg
时间窗: Screening visit
We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia
Assessment of perception of joint pain
时间窗: Screening visit
We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).
Assessment of the status joint
时间窗: Screening visit
We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status
Evaluation of the performance of activities of daily living
时间窗: Screening visit
We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
Assessment of physical performance of patients with hemophilia
时间窗: Screening visit
We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
Assessment of personality traits of children
时间窗: Screening visit
We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
Evaluation of perceived quality of life for patients with hemophilia
时间窗: Screening visit
We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .
次要结局
- Clinical variables of patients with hemophilia(Screening visit)
- Socio-demographic variables of patients with hemophilia(Screening visit)
研究者
RUBÉN CUESTA-BARRIUSO
PhD
Universidad Católica San Antonio de Murcia