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出境医 / 临床实验 / Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Moderate Hemophilia Arthropathy | Other: Gait analysis | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile) |
| Actual Study Start Date : | November 29, 2019 |
| Actual Primary Completion Date : | September 4, 2020 |
| Actual Study Completion Date : | September 4, 2020 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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 Outcome Measures :
- 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.
- 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))
- 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))
- 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))
- 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
- evaluation of bleeding and possible increase in synovial angiogenesis [ Time Frame: during gait analysis and clinical examination (1 hour) ]Measure of doppler activity
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| 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) | |
| Nantes, France | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Alban Fouasson Chailloux, Dr | Nantes University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||
| First Posted Date ICMJE | July 18, 2019 | ||||
| Last Update Posted Date | October 19, 2020 | ||||
| Actual Study Start Date ICMJE | November 29, 2019 | ||||
| Actual Primary Completion Date | September 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile) | ||||
| Official Title ICMJE | Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile) | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: 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. Masking: None (Open Label)Primary Purpose: Prevention |
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| Condition ICMJE |
|
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| Intervention ICMJE | 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.
|
||||
| Study Arms ICMJE | Experimental: Moderate hemophiliac patients
Each participant will perform a gait analysis and clinical examination
Intervention: Other: Gait analysis
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
24 | ||||
| Original Estimated Enrollment ICMJE |
35 | ||||
| Actual Study Completion Date ICMJE | September 4, 2020 | ||||
| Actual Primary Completion Date | September 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04024176 | ||||
| Other Study ID Numbers ICMJE | RC18_0271 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Nantes University Hospital | ||||
| Study Sponsor ICMJE | Nantes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Nantes University Hospital | ||||
| Verification Date | October 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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