Multidisciplinary Evaluation of Patients With Hemophilia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multidisciplinary Assessment of the Physical, Functional and Psychosocial Alterations in Patients With Hemophilia. An Observational Study.

Conditions
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Haemophilia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables. | |
| Control group<br>Children without hemophilia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Joint Damage | Measurement with Haemophilia Joint Health Score 2.1 (HJHS) | Screening visit | 
| Assess the Perception of Quality of Life | Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE). | Screening visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Clinical Patient Variables | Hemophilia type measuring (A or B) | Screening visit | 
| Measure of Weight | Measure of weight | Screening visit (pretreatment assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia, Arthropathy, Range of motion, Strength, Proprioception, Gait, Quality of Life.