Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia (HE-BALANCE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemophilia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Recruiting
    • Universidad Católica San Antonio, Murcia
    • Sub-Investigator: JUAN JOSÉ RODRÍGUEZ JUAN, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Murcia Regional Hemophilia Association

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with hemophilia; Patients with hemophilia who meet the inclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the range of motion	Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).	Screening visit
Assess the muscular strength	Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).	Screening visit
Assess the joint pain	Joint pain (VAS scale with the use of a pressure algometer).	Screening visit
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
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
Assess the contractile activity	Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).	Screening visit
Assess the state joint	State joint (applying Hemophilia Joint Health Score questionnaire).	Screening visit
Assess the list of activities	List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).	Screening visit
Assess the physical performance	Perception of physical performance (with the HEP-Test-Q questionnaire)	Screening visit
Assess the health Profile	Health Profile (using the scale Nottingham health profile)	Screening visit
Assess the quality of life	Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).	Screening visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Age, sex, weight of the patients with hemophilia	Screening visit
Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors	Screening visit
Frequency of joint bleeds in the previous month and bleeding during the assessment	Screening visit

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Quality of Life; Gait; Range of Motion; Arthropathy; Strength; Proprioception; Hemophilia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: UCAM-2