- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824798
Gait Evaluation in Haemophiliac Patients (GAIT_GENERAL)
July 10, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
haemophilia A or B, mild, moderate or severe.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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haemophiliacs A and B
haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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evaluate specific changes in gait in patients suffering from haemophilic arthropathy
Time Frame: from inclusion in the study until 1 year after inclusion
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from inclusion in the study until 1 year after inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: sebastien lobet, sebastien.lobet@uclouvain.be
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.1365-2516.2010.02245.x. Epub 2010 Apr 7.
- 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.
- 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.2012.01.009. Epub 2012 Feb 29.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 16, 2009
First Submitted That Met QC Criteria
January 16, 2009
First Posted (Estimate)
January 19, 2009
Study Record Updates
Last Update Posted (Actual)
July 11, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- READ-LOBET-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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