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Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04024176
Enrollment
24
Registered
2019-07-18
Start date
2019-11-29
Completion date
2020-09-04
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy, Moderate Hemophilia

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.

Interventions

OTHERGait analysis

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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease :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 :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 :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

Secondary

MeasureTime frameDescription
Calculation of the Gait profile Score (GPS)during gait analysis and clinical examination (1 hour)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.
Assessment of joint painduring gait analysis and clinical examination (1 hour)pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))
Assessment of joint healthduring gait analysis and clinical examination (1 hour)Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))
X-rays of target jointsduring gait analysis and clinical examination (1 hour)Evaluated by Pettersson's score for hips, knees and ankles (score from 0 (normal score) to 10 (worse score))
Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and kneesduring gait analysis and clinical examination (1 hour)Ultrasound of knees and ankles
evaluation of bleeding and possible increase in synovial angiogenesisduring gait analysis and clinical examination (1 hour)Measure of doppler activity

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlban Fouasson Chailloux, Dr

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026