Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

NCT04024176 | Completed

• 1 other identifier: RC18_0271
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Moderate Hemophilia; Arthropathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Calculation of the Gait profile Score (GPS)

  during gait analysis and clinical examination (1 hour)

• Assessment of joint pain

  during gait analysis and clinical examination (1 hour)

• Assessment of joint health

  during gait analysis and clinical examination (1 hour)

• X-rays of target joints

  during gait analysis and clinical examination (1 hour)

• Look for synovial hypertrophy by measuring the variation in synovial thickness of the ankles and knees

  during gait analysis and clinical examination (1 hour)

Study Arms (1)

Moderate hemophiliac patients

EXPERIMENTAL

Each participant will perform a gait analysis and clinical examination

Other: Gait analysis

Interventions

Gait analysis OTHER

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.

Moderate hemophiliac patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)

Nantes, France

Location

Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital)

Nantes, France

Location

Regional Hemophilia Treatment Centre (Nantes University Hospital)

Nantes, France

Location

Rheumatology department (Nantes University Hospital)

Nantes, France

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Alban Fouasson Chailloux, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: July 18, 2019
• Study Start: November 29, 2019
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

FR (4)