Clinical trial NCT04024176: Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
Official title: Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Hemophilia
Arthropathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant women
* Minor
* Majors under guardianship or curatorship
* Refusal to participate;
* Amputee of a lower limb
* Need for technical walking assistance (walking sticks, walker,...).
* 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

Primary outcomes:
measure: Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease :
timeFrame: during gait analysis and clinical examination (1 hour)
measure: Analysis of kinematic datas of the gait in moderate hemophiliac patients according to the duration of disease :
timeFrame: during gait analysis and clinical examination (1 hour)
measure: Analysis of dynamic datas of the gait in moderate hemophiliac patients according to the duration of disease :
timeFrame: during gait analysis and clinical examination (1 hour)
Secondary outcomes:
measure: Calculation of the Gait profile Score (GPS)
timeFrame: during gait analysis and clinical examination (1 hour)
measure: Assessment of joint pain
timeFrame: during gait analysis and clinical examination (1 hour)
measure: Assessment of joint health
timeFrame: during gait analysis and clinical examination (1 hour)
measure: X-rays of target joints
timeFrame: during gait analysis and clinical examination (1 hour)
measure: Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and knees
timeFrame: during gait analysis and clinical examination (1 hour)
measure: evaluation of bleeding and possible increase in synovial angiogenesis
timeFrame: during gait analysis and clinical examination (1 hour)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)
city: Nantes
country: France
facility: Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital)
city: Nantes
country: France
facility: Regional Hemophilia Treatment Centre (Nantes University Hospital)
city: Nantes
country: France
facility: Rheumatology department (Nantes University Hospital)
Study officials:
affiliation: Nantes University Hospital
name: Alban Fouasson Chailloux, Dr
role: PRINCIPAL_INVESTIGATOR
References: