NCT02198430

Brief Summary

Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:

  • Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis.
  • Descriptive study of the alterations of periarticular muscle strength as a result of acute processes 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 joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography.
  • Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

July 22, 2014

Results QC Date

June 29, 2016

Last Update Submit

August 26, 2016

Conditions

Haemophilia

Keywords

HaemophiliaArthropathyRange of motionStrengthProprioceptionGaitQuality of Life.

Outcome Measures

Primary Outcomes (2)

  • Assess the Joint Damage

    Measurement with Haemophilia Joint Health Score 2.1 (HJHS)

    Screening visit

  • Assess the Perception of Quality of Life

    Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).

    Screening visit

Secondary Outcomes (2)

  • Assessment of Clinical Patient Variables

    Screening visit

  • Measure of Weight

    Screening visit (pretreatment assessment)

Study Arms (2)

Patients

Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.

Control group

Children without hemophilia

Eligibility Criteria

Age8 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with haemophilia attending hemophilia shelters organized by the Federación Española de Hemofilia (Fedhemo) in the Centro de Formación Permanente en Hemofilia La Charca (Murcia, Spain).

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 loading.
  • Patients with or without inhibitors.

You may not qualify if:

  • Patients without prior walking 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Murcia

Murcia, Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Hemophilia AJoint Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMusculoskeletal Diseases

Results Point of Contact

Title
Dr. Rubén Cuesta-Barriuso
Organization
Real Fundación Victoria Eugenia
ruben.cuestab@gmail.com
+34913146508

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Catholic University San Antonio of Murcia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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 22, 2014

First Posted

July 23, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

October 20, 2016

Results First Posted

October 20, 2016

Record last verified: 2016-06

Locations

ES(1)