Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

Not Applicable

Completed

• Conditions: Arthropathy; Moderate Hemophilia
• Interventions: Other: Gait analysis

• Registration Number: NCT04024176
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-11-29
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate hemophiliac patients	Gait analysis	Each participant will perform a gait analysis and clinical examination

Primary Outcome Measures

Name	Time	Method
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
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 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

Secondary Outcome Measures

Name	Time	Method
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 pain	during gait analysis and clinical examination (1 hour)	pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))
Assessment of joint health	during gait analysis and clinical examination (1 hour)	Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))
X-rays of target joints	during 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 knees	during gait analysis and clinical examination (1 hour)	Ultrasound of knees and ankles
evaluation of bleeding and possible increase in synovial angiogenesis	during gait analysis and clinical examination (1 hour)	Measure of doppler activity

Trial Locations

Locations (4)

Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital); 🇫🇷 Nantes, France

Rheumatology department (Nantes University Hospital); 🇫🇷 Nantes, France

Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital); 🇫🇷 Nantes, France

Regional Hemophilia Treatment Centre (Nantes University Hospital); 🇫🇷 Nantes, France