Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

NCT ID: NCT04024176

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2020-09-04

Brief Summary

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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

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Conditions

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Moderate Hemophilia Arthropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate hemophiliac patients

Each participant will perform a gait analysis and clinical examination

Group Type EXPERIMENTAL

Gait analysis

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alban Fouasson Chailloux, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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

Nantes, , France

Site Status

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

Nantes, , France

Site Status

Regional Hemophilia Treatment Centre (Nantes University Hospital)

Nantes, , France

Site Status

Rheumatology department (Nantes University Hospital)

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC18_0271

Identifier Type: -

Identifier Source: org_study_id

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