Transcultural Multidisciplinary Evaluation of Patients With Hemophili

NCT02199639 | Unknown

• 1 other identifier: ibHEro
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Haemophilia

Keywords

Haemophilia; Arthropathy; Range of Movement; Strength; Proprioception; Gait; Quality of Life

Outcome Measures

Primary Outcomes (8)

• Assessment of range of motion of elbow, knee and ankle

  We will use a goniometric evaluation, along the lines indicated by Querol for assessing the range of motion in patients with hemophilia

  Screening visit

• Assessment of muscle strength of arm, thigh and leg

  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

  Screening visit

• Assessment of perception of joint pain

  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).

  Screening visit

• Assessment of the status joint

  We will use the specific questionnaire haemophilia: Haemophilia Joint Healts Score (HJHS) for the assessment of joint status

  Screening visit

• Evaluation of the performance of activities of daily living

  We will use the questionnaire Haemophilia Activities List (HAL), specific for patients with hemophilia

  Screening visit

• Assessment of physical performance of patients with hemophilia

  We will use the Physical Functioning scale (HEP-Test-Q), specific for patients with hemophilia

  Screening visit

• Assessment of personality traits of children

  We will use the questionnaire Eysenck Personality Questionnaire Junior (EPQJ)

  Screening visit

• Evaluation of perceived quality of life for patients with hemophilia

  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 .

  Screening visit

Secondary Outcomes (2)

• Clinical variables of patients with hemophilia

  Screening visit

• Socio-demographic variables of patients with hemophilia

  Screening visit

Study Arms (3)

Spain

Group of patients with hemophilia recruited in the Region of Murcia (Spain) and evaluated in the Universidad Católica San Antonio between June and July 2014.

El Salvador

Group of patients with hemophilia recruited in the city of San Salvador (El Salvador) and evaluated in the Hospital Nacional Rosales and the Hospital Nacional de niños "Benjamín Bloom" from San Salvador in April 2014.

Bolivia

Group of patients with hemophilia recruited in the city of Santa Cruz (Bolivia) and evaluated at the Hospital Nacional de niños in Santa Cruz August 2014.

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with haemophilia from Spain, El Salvador and Bolivia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, Murcia, 30107, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Joint Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases

Study Officials

• RUBEN CUESTA-BARRIUSO, PhD

  Universidad Católica San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUBÉN CUESTA-BARRIUSO, PhD

CONTACT

968278806; ruben.cuestab@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2014-03

Locations

ES (1)