Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia

Hemophilia Clinical Trial

— HE-BALANCE  

Official title:

Assessment and Identification of Proprioceptive and Functional Changes in Patients With Hemophilia of the Region of Murcia.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02165592
• Other study ID #: UCAM-2
• Secondary ID: UCAM-2
• Status: Unknown status
• Phase: N/A
• First received: June 13, 2014
• Last updated: October 7, 2015
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Universidad Católica San Antonio de Murcia
• Contact: RUBÉN CUESTA-BARRIUSO, PhD
• Email: rcuesta[@]ucam.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.

• Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.

• Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.

• Detect the biomechanical changes 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.

Description:

Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis in lower limbs.

Descriptive study of alterations in the strength of the periarticular muscles of lower limbs as a result of acute conditions or the development of chronic articular sequelae.

Descriptive study of the biomechanical alterations in weight-bearing joints of lower limbs and their impact on gait in patients with hemophilia.

Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with hemophilia A and B

• Patients of all ages (from 6 to 70 years).

• With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.

• Residents in the Autonomous Community of the Region of Murcia.

Exclusion Criteria:

• Patients without ambulation

• Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).

• Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio, Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the range of motion	Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).	Screening visit
Primary	Assess the muscular strength	Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).	Screening visit
Primary	Assess the joint pain	Joint pain (VAS scale with the use of a pressure algometer).	Screening visit
Primary	Assess the variables of strength	Assessment of variables of vertical strength, medio-lateral and anterior-posterior in jump and incorporation from the sitting position.	Screening visit
Primary	Assess the peak force	Functional assessment of peak force, force production per unit time and subsequent stabilization in standing (in jump and in the passage from the sitting position to standing position, respectively, using a force platform).	Screening visit
Primary	Assess the contractile activity	Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).	Screening visit
Primary	Assess the state joint	State joint (applying Hemophilia Joint Health Score questionnaire).	Screening visit
Primary	Assess the list of activities	List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).	Screening visit
Primary	Assess the physical performance	Perception of physical performance (with the HEP-Test-Q questionnaire)	Screening visit
Primary	Assess the health Profile	Health Profile (using the scale Nottingham health profile)	Screening visit
Primary	Assess the quality of life	Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).	Screening visit
Secondary	Age, sex, weight of the patients with hemophilia		Screening visit
Secondary	Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors		Screening visit
Secondary	Frequency of joint bleeds in the previous month and bleeding during the assessment		Screening visit