Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

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.

Study Overview

• Status: Completed
• Conditions: Arthropathy; Moderate Hemophilia
• Intervention / Treatment: Other: Gait analysis

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, 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)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Moderate hemophiliac patients; Each participant will perform a gait analysis and clinical examination	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Assessment of joint pain	pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))	during gait analysis and clinical examination (1 hour)
Assessment of joint health	Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))	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))	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	during gait analysis and clinical examination (1 hour)
evaluation of bleeding and possible increase in synovial angiogenesis	Measure of doppler activity	during gait analysis and clinical examination (1 hour)

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Alban Fouasson Chailloux, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2019
• Primary Completion (ACTUAL): September 4, 2020
• Study Completion (ACTUAL): September 4, 2020

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (ACTUAL): July 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RC18_0271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No