Transcultural Multidisciplinary Evaluation of Patients With Hemophili

• Conditions: Patients With Haemophilia

• Registration Number: NCT02199639
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of range of motion of elbow, knee and ankle	Screening visit	We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia
Assessment of muscle strength of arm, thigh and leg	Screening visit	We will use a measure of muscular balance with the guidelines outlined by Daniels, with the adaptation of Querol for assessing muscle strength in patients with hemophilia
Assessment of perception of joint pain	Screening visit	We will use the visual analogue scale (VAS) for the assessment of joint pain in patients with hemophilia, with a scale from 0 (no pain) to 10 (maximum pain).
Assessment of the status joint	Screening visit	We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status
Evaluation of the performance of activities of daily living	Screening visit	We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia
Assessment of physical performance of patients with hemophilia	Screening visit	We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia
Assessment of personality traits of children	Screening visit	We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)
Evaluation of perceived quality of life for patients with hemophilia	Screening visit	We will use the Hemophilia-QoL and the Child Health and Illness Profile (CHIP-CE) questionnaires for children; and the Hemophilia-QoL and A36 and 36 Health Survey (SF36) questionnairesfor adults .

Secondary Outcome Measures

Name	Time	Method
Clinical variables of patients with hemophilia	Screening visit	Age (years); weight (kg); Size (cm); type of haemophilia (A or B); severity of hemophilia (severe / moderate / mild); pharmacological treatment (prophylactic / on demand); presence of inhibitors; central venous catheter; family history of hemophilia; hemarthrosis in the last month; arthropathy diagnosed in some joint; use of orthoses
Socio-demographic variables of patients with hemophilia	Screening visit	Number of hospital visits per year (reason); Distance to hospital (km); Academic formation of the patient (university studies / vocational training / basic studies / no studies); academic formation of the parents (university studies / vocational training / basic studies / no studies); patient employment (self-employment / employment has as an employed person / unemployed / retirement); parents employment (self-employment / employment has as an employed person / unemployed / retirement);

Trial Locations

Locations (1)

Universidad Católica San Antonio de Murcia; 🇪🇸 Murcia, Spain