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Transcultural Multidisciplinary Evaluation of Patients With Hemophili

NCT ID: NCT02199639

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Patients With Haemophilia

Keywords

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Haemophilia Arthropathy Range of Movement Strength Proprioception Gait Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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 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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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RUBÉN CUESTA-BARRIUSO

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RUBEN CUESTA-BARRIUSO, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio

Locations

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Universidad Católica San Antonio de Murcia

Murcia, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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RUBÉN CUESTA-BARRIUSO, PhD

Role: CONTACT

Phone: 968278806

Email: [email protected]

Facility Contacts

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RUBÉN CUESTA-BARRIUSO, PhD

Role: primary

ANA TORRES-ORTUÑO, PhD

Role: backup

Other Identifiers

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ibHEro

Identifier Type: -

Identifier Source: secondary_id

ibHEro

Identifier Type: -

Identifier Source: org_study_id