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临床试验/NCT02165592
NCT02165592Unknown不适用

Assessment and Identification of Proprioceptive and Functional Changes in Patients With Hemophilia of the Region of Murcia.

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Assess the range of motion

研究概览

简要总结

Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.

  • Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.
  • Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.
  • Detect the biomechanical changes of the lower limbs and their impact on gait in patients with hemophilia.
  • Assess 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 hemophilia patients with and without a history of hemarthrosis in lower limbs.

Descriptive study of alterations in the strength of the periarticular muscles of lower limbs as a result of acute conditions or the development of chronic articular sequelae.

Descriptive study of the biomechanical alterations in weight-bearing joints of lower limbs and their impact on gait in patients with hemophilia.

Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions 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
Cross Sectional

入排标准

年龄范围
6 Years 至 70 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with hemophilia A and B
  • Patients of all ages (from 6 to 70 years).
  • With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
  • Residents in the Autonomous Community of the Region of Murcia.

排除标准

  • Patients without ambulation
  • 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 range of motion

时间窗: Screening visit

Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).

Assess the muscular strength

时间窗: Screening visit

Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).

Assess the joint pain

时间窗: Screening visit

Joint pain (VAS scale with the use of a pressure algometer).

Assess the variables of strength

时间窗: Screening visit

Assessment of variables of vertical strength, medio-lateral and anterior-posterior in jump and incorporation from the sitting position.

Assess the peak force

时间窗: Screening visit

Functional assessment of peak force, force production per unit time and subsequent stabilization in standing (in jump and in the passage from the sitting position to standing position, respectively, using a force platform).

Assess the contractile activity

时间窗: Screening visit

Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).

Assess the state joint

时间窗: Screening visit

State joint (applying Hemophilia Joint Health Score questionnaire).

Assess the list of activities

时间窗: Screening visit

List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).

Assess the physical performance

时间窗: Screening visit

Perception of physical performance (with the HEP-Test-Q questionnaire)

Assess the health Profile

时间窗: Screening visit

Health Profile (using the scale Nottingham health profile)

Assess the quality of life

时间窗: Screening visit

Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).

次要结局

  • Age, sex, weight of the patients with hemophilia(Screening visit)
  • Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors(Screening visit)
  • Frequency of joint bleeds in the previous month and bleeding during the assessment(Screening visit)

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

RUBÉN CUESTA-BARRIUSO

PhD

Universidad Católica San Antonio de Murcia

研究点 (1)

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