Moderate HemophiliaNCT04024176
Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
A study testing Gait analysis in people with Moderate Hemophilia and Arthropathy, run by Nantes University Hospital at 4 sites in France.
Trial summary
The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Hemophilia, Arthropathy
- What is being tested?
- Gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Nov 2019to 4 Sep 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have moderate Hemophilia A or B.
- Have understood the protocol and signed its consent to participate.
- Patient able to perform a walking test.
- Patient affiliated to a social security system
Who cannot join
- Pregnant women
- Minor
- Majors under guardianship or curatorship
- Refusal to participate;
- Amputee of a lower limb
- Need for technical walking assistance (walking sticks, walker,...).
Show all 13Show fewer
- Extensive dermatitis of the lower limbs (need for sensor installation for gait analysis);
- Known NYHA (New York Heart Association) grade III or IV heart failure (resting dyspnea);
- Unstable angina or myocardial infarction within three months of inclusion
- Known severe respiratory disease;
- Parkinson's disease, hemiplegia or paraplegia
- Patient unable to understand the objectives or instructions of the study
- Intercurrent pathology likely to modify walking abilities
Trial locations and contacts
4 sites in 1 country.
France4 sites
Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)
Nantes
Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital)
Nantes
Regional Hemophilia Treatment Centre (Nantes University Hospital)
Nantes
Rheumatology department (Nantes University Hospital)
Nantes
About this study
Official title: Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.
- Conditions
- Moderate Hemophilia, Arthropathy
- Being tested
- Gait analysis
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
The duration of participation of each subject is equal to the duration of the examination, i.e. approximately 30 minutes for the gait analysis and 30 minutes for the clinical examination (including 10 minutes for completing the questionnaire). The experiments will be carried out in a single measurement session, including several steps.
| Study group | Role | What they receive |
|---|---|---|
| Moderate hemophiliac patients | Experimental | Each participant will perform a gait analysis and clinical examination Receives: Other: Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease :
Analysis of gait parameters
Measured: during gait analysis and clinical examination (1 hour)
Analysis of kinematic datas of the gait in moderate hemophiliac patients according to the duration of disease :
motion capture by optoelectronic system: articular amplitudes at different walking times
Measured: during gait analysis and clinical examination (1 hour)
Analysis of dynamic datas of the gait in moderate hemophiliac patients according to the duration of disease :
accelerations measured by the force platforms during the passage of the subject: moments of force at the different joints during the different walking times
Measured: during gait analysis and clinical examination (1 hour)
Secondary outcomes (6)
Calculation of the Gait profile Score (GPS)
As the Gait Profile Score represents the difference between the patient's data and the average from the reference dataset, the higher the Gait Profile Score value is, the less physiological gait pattern is.
Measured: during gait analysis and clinical examination (1 hour)
Assessment of joint pain
pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))
Measured: during gait analysis and clinical examination (1 hour)
Assessment of joint health
Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))
Measured: during gait analysis and clinical examination (1 hour)
X-rays of target joints
Evaluated by Pettersson's score for hips, knees and ankles (score from 0 (normal score) to 10 (worse score))
Measured: during gait analysis and clinical examination (1 hour)
Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and knees
Ultrasound of knees and ankles
Measured: during gait analysis and clinical examination (1 hour)
evaluation of bleeding and possible increase in synovial angiogenesis
Measure of doppler activity
Measured: during gait analysis and clinical examination (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start29 Nov 2019
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate HemophiliaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will perform the quantified gait analysis examination and a clinical examination. The experiments will be carried out in a single measurement session, including several steps.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alban Fouasson Chailloux, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024176
- Sponsor's protocol ID
- RC18_0271
- Status last verified
- Oct 2020
- First submitted
- 7 May 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fouasson-Chailloux A, Leboeuf F, Maugars Y, Trossaert M, Menu P, Rannou F, Vinatier C, Guicheux J, Gross R, Dauty M. Gait Alteration Due to Haemophilic Arthropathies in Patients with Moderate Haemophilia. Int J Environ Res Public Health. 2022 Jun 20;19(12):7527. doi: 10.3390/ijerph19127527.
PubMed 35742774
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
- ClinicalTrials.gov ID
- NCT04024176
- Acronym / sponsor ID
- RC18_0271
- Conditions
- Moderate Hemophilia, Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- 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.
The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will perform the quantified gait analysis examination and a clinical examination. The experiments will be carried out in a single measurement session, including several steps.
| Arm | Type | Receives |
|---|---|---|
| Moderate hemophiliac patients | Experimental | Other: Gait analysisEach participant will perform a gait analysis and clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have moderate Hemophilia A or B.
- Have understood the protocol and signed its consent to participate.
- Patient able to perform a walking test.
- Patient affiliated to a social security system
Key exclusion criteria (13 listed)
- Pregnant women
- Minor
- Majors under guardianship or curatorship
- Refusal to participate;
- Amputee of a lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysisThe duration of participation of each subject is equal to the duration of the examination, i.e. approximately 30 minutes for the gait analysis and 30 minutes for the clinical examination (including 10 minutes for completing the questionnaire). The experiments will be carried out in a single measurement session, including several steps. | Other | Moderate hemophiliac patients |
Primary outcome
Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease :
Time frame: during gait analysis and clinical examination (1 hour)
Analysis of gait parameters
Analysis of kinematic datas of the gait in moderate hemophiliac patients according to the duration of disease :
Time frame: during gait analysis and clinical examination (1 hour)
motion capture by optoelectronic system: articular amplitudes at different walking times
Analysis of dynamic datas of the gait in moderate hemophiliac patients according to the duration of disease :
Time frame: during gait analysis and clinical examination (1 hour)
accelerations measured by the force platforms during the passage of the subject: moments of force at the different joints during the different walking times
6 secondary outcomes
Calculation of the Gait profile Score (GPS)
Time frame: during gait analysis and clinical examination (1 hour)
Assessment of joint pain
Time frame: during gait analysis and clinical examination (1 hour)
Assessment of joint health
Time frame: during gait analysis and clinical examination (1 hour)
X-rays of target joints
Time frame: during gait analysis and clinical examination (1 hour)
Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and knees
Time frame: during gait analysis and clinical examination (1 hour)
evaluation of bleeding and possible increase in synovial angiogenesis
Time frame: during gait analysis and clinical examination (1 hour)
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 14 Sep 2026.
- Results publication: PubMed 35742774Fouasson-Chailloux A, Leboeuf F, Maugars Y, Trossaert M, Menu P, Rannou F, Vinatier C, Guicheux J, Gross R, Dauty M. Gait Alteration Due to Haemophilic Arthropathies in Patients with Moderate Haemophilia. Int J Environ Res Public Health. 2022 Jun 20;19(12):7527. doi: 10.3390/ijerph19127527.
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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.
Alban Fouasson Chailloux, Dr principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis in people with Moderate Hemophilia and Arthropathy, run by Nantes University Hospital at 4 sites in France.
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 4 inclusion and 13 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease : (time frame: during gait analysis and clinical examination (1 hour)). The study lists 3 primary outcomes in all. 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 NCT04024176, which also lists 1 linked publication.
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 14 Sep 2026.