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NCT00824798 Clinical Trial

Gait Evaluation in Haemophiliac Patients

Hemophilia A Clinical Trial

— GAIT_GENERAL  

Official title:
Gait Evaluation in Haemophiliac Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00824798
Other study ID # READ-LOBET-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2009
Est. completion date January 2011

Study information
Verified date July 2019
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability and mobility, axial deviation, deterioration and decreased function are the most frequent complains in patients with severe haemophilic arthropathy In this context, the purpose of our study is to examine and analyse specific changes in gait in patients suffering from haemophilic arthropathy and determine the impact on health-related quality of life in terms of conceptual components of pain and stiffness, psychosocial stress, disability, and activity limitations as recommended by the International Classification of Function (ICF) recently published by the World Health Organization.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 5 Years to 80 Years
Eligibility Inclusion Criteria:

- haemophilia A or B

- aged more than 4 years

Exclusion Criteria:

- impossibility to walk on a treadmill

- recent joint haemarthrosis or muscle haematoma

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Lobet S, Detrembleur C, Francq B, Hermans C. Natural progression of blood-induced joint damage in patients with haemophilia: clinical relevance and reproducibility of three-dimensional gait analysis. Haemophilia. 2010 Sep 1;16(5):813-21. doi: 10.1111/j.13 — View Citation

Lobet S, Detrembleur C, Hermans C. Impact of multiple joint impairments on the energetics and mechanics of walking in patients with haemophilia. Haemophilia. 2013 Mar;19(2):e66-72. doi: 10.1111/hae.12001. Epub 2012 Sep 9. — View Citation

Lobet S, Detrembleur C, Massaad F, Hermans C. Three-dimensional gait analysis can shed new light on walking in patients with haemophilia. ScientificWorldJournal. 2013 May 13;2013:284358. doi: 10.1155/2013/284358. Print 2013. Review. — View Citation

Lobet S, Hermans C, Bastien GJ, Massaad F, Detrembleur C. Impact of ankle osteoarthritis on the energetics and mechanics of gait: the case of hemophilic arthropathy. Clin Biomech (Bristol, Avon). 2012 Jul;27(6):625-31. doi: 10.1016/j.clinbiomech.2012.01.0 — View Citation

Lobet S, Hermans C, Pasta G, Detrembleur C. Body structure versus body function in haemophilia: the case of haemophilic ankle arthropathy. Haemophilia. 2011 May;17(3):508-15. doi: 10.1111/j.1365-2516.2010.02433.x. Epub 2011 Mar 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate specific changes in gait in patients suffering from haemophilic arthropathy from inclusion in the study until 1 year after inclusion
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