NCT02199639|Unknown
Transcultural Multidisciplinary Evaluation of Patients With Hemophili
ibHEro
Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
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ibHEro
Multidisciplinary Evaluation of Patients With Hemophilia of Spain, El Salvador and Bolivia. An Observational Study
Sponsor study identifier
Secondary identifiers
observational
100
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 23, 2014
Actual (reported)July 24, 2014
Actual (reported)August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Clinical variables of patients with hemophilia
Screening visit
Socio-demographic variables of patients with hemophilia
Screening visit
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.
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.
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.
Patients with haemophilia from Spain, El Salvador and Bolivia
Universidad Católica San Antonio de Murcia
Murcia, Murcia, 30107, Spain
RUBEN CUESTA-BARRIUSO, PhD
Universidad Católica San Antonio
First Submitted
July 23, 2014
First Posted
July 24, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Estimated (date passed)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
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2015
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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