Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

October 14, 2020 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 :
Time Frame: during gait analysis and clinical examination (1 hour)
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 :
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
during gait analysis and clinical examination (1 hour)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
during gait analysis and clinical examination (1 hour)
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))
during gait analysis and clinical examination (1 hour)
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))
during gait analysis and clinical examination (1 hour)
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))
during gait analysis and clinical examination (1 hour)
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
during gait analysis and clinical examination (1 hour)
evaluation of bleeding and possible increase in synovial angiogenesis
Time Frame: during gait analysis and clinical examination (1 hour)
Measure of doppler activity
during gait analysis and clinical examination (1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alban Fouasson Chailloux, Dr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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