Clinical trial NCT02198430: Multidisciplinary Evaluation of Patients With Hemophilia
Official title: Multidisciplinary Assessment of the Physical, Functional and Psychosocial Alterations in Patients With Hemophilia. An Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia
Keywords: Haemophilia
Arthropathy
Range of motion
Strength
Proprioception
Gait
Quality of Life.
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 104
Sex: MALE
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia attending hemophilia shelters organized by the Federación Española de Hemofilia (Fedhemo) in the Centro de Formación Permanente en Hemofilia La Charca (Murcia, Spain).

Brief summary: 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.

Detailed description: 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.

Detect biomechanical abnormalities 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.

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 loading.
* Patients with or without inhibitors.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assess the Joint Damage
timeFrame: Screening visit
measure: Assess the Perception of Quality of Life
timeFrame: Screening visit
Secondary outcomes:
measure: Assessment of Clinical Patient Variables
timeFrame: Screening visit
measure: Measure of Weight
timeFrame: Screening visit (pretreatment assessment)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Catholic University San Antonio of Murcia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: