Clinical trial NCT02199639: Transcultural Multidisciplinary Evaluation of Patients With Hemophili
Official title: Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Haemophilia
Keywords: Haemophilia
Arthropathy
Range of Movement
Strength
Proprioception
Gait
Quality of Life
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 100
Sex: MALE
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia from Spain, El Salvador and Bolivia

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of range of motion of elbow, knee and ankle
timeFrame: Screening visit
measure: Assessment of muscle strength of arm, thigh and leg
timeFrame: Screening visit
measure: Assessment of perception of joint pain
timeFrame: Screening visit
measure: Assessment of the status joint
timeFrame: Screening visit
measure: Evaluation of the performance of activities of daily living
timeFrame: Screening visit
measure: Assessment of physical performance of patients with hemophilia
timeFrame: Screening visit
measure: Assessment of personality traits of children
timeFrame: Screening visit
measure: Evaluation of perceived quality of life for patients with hemophilia
timeFrame: Screening visit
Secondary outcomes:
measure: Clinical variables of patients with hemophilia
timeFrame: Screening visit
measure: Socio-demographic variables of patients with hemophilia
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: RUBEN CUESTA-BARRIUSO, PhD
role: PRINCIPAL_INVESTIGATOR
References: