Multidisciplinary Evaluation of Patients With Hemophilia

NCT ID: NCT02198430

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Haemophilia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.

No interventions assigned to this group

Control group

Children without hemophilia

No interventions assigned to this group

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

ANA TORRES-ORTUÑO

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University San Antonio of Murcia

Locations

Universidad de Murcia

Murcia, Murcia, Spain

Countries

Spain

Other Identifiers

HOLISTIC

Identifier Type: -

Identifier Source: secondary_id

Hemo-HOLISTIC

Identifier Type: -

Identifier Source: org_study_id