Gait Evaluation in Haemophiliac Patients

This study is enrolling participants by invitation only.

Sponsored by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00638001

Purpose

The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the orthoses' impact on foot health-related quality of life.

Condition	Intervention	Phase
Haemophilia A Haemophilia B	Device: custom-molded insoles and custom-molded shoes	Phase IV

Genetics Home Reference related topics: hemophilia L1 syndrome

MedlinePlus related topics: Foot Health Hemophilia

Drug Information available for: Factor IX

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

Gait analysis, foot pressure measurement, specific joint score [ Time Frame: To, T1 (3months) and T2 (6months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

custom-made insoles in "PELITE" foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy
custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy

Eligibility

Ages Eligible for Study:	13 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

haemophilia A or B, aged more than 13 years

Exclusion Criteria:

impossibility to walk on a treadmill
recent joint haemarthrosis or muscle haematoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638001

Locations

Belgium
cliniques Universitaires Saint Luc
Brussels, Belgium, 1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

More Information

Responsible Party:	service d'hématologie ( Cliniques universitaires Saint-Luc )
Study ID Numbers:	lobet01
Study First Received:	February 26, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00638001
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

patients with haemophilia A moderate or severe
patients with haemophilia B moderate or severe

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009