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Completed

NCT Number: NCT04024176

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.

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Key information

Conditions

Moderate Hemophilia Arthropathy Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: during gait analysis and clinical examination (1 hour)

    Analysis of gait parameters

  2. Analysis of kinematic datas of the gait in moderate hemophiliac patients according to the duration of disease :

    Time frame: during gait analysis and clinical examination (1 hour)

    motion capture by optoelectronic system: articular amplitudes at different walking times

  3. Analysis of dynamic datas of the gait in moderate hemophiliac patients according to the duration of disease :

    Time frame: 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 outcomes

  1. Calculation of the Gait profile Score (GPS)

    Time frame: 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.

  2. Assessment of joint pain

    Time frame: during gait analysis and clinical examination (1 hour)

    pain (anlog visual scale from 0 (no pain) to 10 (maximal pain))

  3. Assessment of joint health

    Time frame: during gait analysis and clinical examination (1 hour)

    Hemophilia Joint Health score (from 0 (best score) to 25 (worse score))

  4. X-rays of target joints

    Time frame: 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))

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

    Time frame: during gait analysis and clinical examination (1 hour)

    Ultrasound of knees and ankles

  6. evaluation of bleeding and possible increase in synovial angiogenesis

    Time frame: during gait analysis and clinical examination (1 hour)

    Measure of doppler activity

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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