Hemophilia AGAIT_GENERALNCT00824798
Gait Evaluation in Haemophiliac Patients
An observational study of Hemophilia A and Hemophilia B, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 5 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A, Hemophilia B
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: haemophilia A or B, mild, moderate or severe.
Who may be able to join
- haemophilia A or B
- aged more than 4 years
Who cannot join
- impossibility to walk on a treadmill
- recent joint haemarthrosis or muscle haematoma
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- gait, haemophilia, arthropathy
- Medical subject headings
- Hemophilia A, Hemophilia B, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| haemophiliacs A and B | haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate specific changes in gait in patients suffering from haemophilic arthropathy
Measured: from inclusion in the study until 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sebastien lobet, Principal investigator, sebastien.lobet@uclouvain.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824798
- Sponsor's protocol ID
- READ-LOBET-02
- Acronym
- GAIT_GENERAL
- Status last verified
- Jul 2019
- First submitted
- 16 Jan 2009
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20398067Lobet 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.
PubMed 21371180Lobet 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). 2012 Jul;27(6):625-31. doi: 10.1016/j.clinbiomech.2012.01.009. Epub 2012 Feb 29.
PubMed 22381586Lobet 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.
PubMed 22958138Lobet 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.
PubMed 23766686
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Evaluation in Haemophiliac Patients
- ClinicalTrials.gov ID
- NCT00824798
- Acronym / sponsor ID
- GAIT_GENERAL / READ-LOBET-02
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- gait, haemophilia, arthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haemophiliacs A and B | – | –haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- haemophilia A or B, mild, moderate or severe.
Key inclusion criteria (2 listed)
- haemophilia A or B
- aged more than 4 years
Key exclusion criteria (2 listed)
- impossibility to walk on a treadmill
- recent joint haemarthrosis or muscle haematoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate specific changes in gait in patients suffering from haemophilic arthropathy
Time frame: from inclusion in the study until 1 year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Results publication: PubMed 20398067Lobet 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.
- Results publication: PubMed 21371180Lobet 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.
- Results publication: PubMed 22381586Lobet 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). 2012 Jul;27(6):625-31. doi: 10.1016/j.clinbiomech.2012.01.009. Epub 2012 Feb 29.
- Results publication: PubMed 22958138Lobet 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.
- Results publication: PubMed 23766686Lobet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sebastien lobet principal investigator
sebastien.lobet@uclouvain.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate specific changes in gait in patients suffering from haemophilic arthropathy (time frame: from inclusion in the study until 1 year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824798, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.