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Completed

NCT Number: NCT02198430

Multidisciplinary Evaluation of Patients With Hemophilia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assess the Joint Damage

    Time frame: Screening visit

    Measurement with Haemophilia Joint Health Score 2.1 (HJHS)

  2. Assess the Perception of Quality of Life

    Time frame: Screening visit

    Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).

Secondary outcomes

  1. Assessment of Clinical Patient Variables

    Time frame: Screening visit

    Hemophilia type measuring (A or B)

  2. Measure of Weight

    Time frame: Screening visit (pretreatment assessment)

    Measure of weight

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Acronym: HOLISTIC

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 23, 2014
Registry last updated
Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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