Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024176
• Other study ID #: RC18_0271
• Status: Completed
• Phase: N/A
• Start date: November 29, 2019
• Est. completion date: September 4, 2020

Study information

• Verified date: October 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy
• Joint Diseases
• Moderate Hemophilia

Intervention

Other:
• Gait 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.

Locations

Country	Name	City	State
France	Department of Physical Medicine and Locomotive Rehabilitation (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	Rheumatology department (Nantes University Hospital)	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of spatio-temporal parameters of the gait in moderate hemophiliac patients according to the duration of disease :	Analysis of gait parameters	during gait analysis and clinical examination (1 hour)
Primary	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	during gait analysis and clinical examination (1 hour)
Primary	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	during gait analysis and clinical examination (1 hour)
Secondary	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.	during gait analysis and clinical examination (1 hour)
Secondary	Assessment of joint pain	pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))	during gait analysis and clinical examination (1 hour)
Secondary	Assessment of joint health	Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))	during gait analysis and clinical examination (1 hour)
Secondary	X-rays of target joints	Evaluated by Pettersson's score for hips, knees and ankles (score from 0 (normal score) to 10 (worse score))	during gait analysis and clinical examination (1 hour)
Secondary	Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and knees	Ultrasound of knees and ankles	during gait analysis and clinical examination (1 hour)
Secondary	evaluation of bleeding and possible increase in synovial angiogenesis	Measure of doppler activity	during gait analysis and clinical examination (1 hour)