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Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients (WALKING-SEP)

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ClinicalTrials.gov Identifier: NCT03756142
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system. Patients are suffering from balance and gait impairments at the early stage of the disease.

85 % of the MS patients report gait disorders, which impact their autonomy and their quality of life and increase the risk of fall.

The three-dimensional analysis of the walking by a motion capture system associated with force platforms allows the quantification of the complex walking disorders, to look for the cause, as well as side effects such as compensation strategies.

According to the 2006 report of the French National Authority for Health, the 3D analysis of walking is essential in chronic pathologies to evaluate and quantify gait disorders. This analysis allows the functional follow-up of the patients throughout their rehabilitation. Some studies, on a small and heterogeneous population of MS patients, showed changes during the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation of lower limbs at early stages of the disease. Only two studies evaluate the joint power during walking in MS patients. However, these studies have some limits.

The 3D analysis of the walking proposed in this study would allow the biomechanical characterization of the gait impairments of MS patients through tasks such as walking, gait initiation and orthostatic posture. This methodology would contribute to adapt treatments and the rehabilitation care, at an early stage of the disease.

From a functional point of view, the gait initiation is an interesting dynamic task to be evaluated. Indeed, it represents the transition between the upright posture and the stabilized walking. Throughout this complex task, a stereotypical motor program is set up during a first phase of anticipatory postural adjustments, which allows the creation of dynamic conditions essential for the execution of the first step. The gait initiation is little documented for MS patients despite the risk of fall clinically highlighted. The articular power during the gait initiation was never estimated in MS patients. On the other hand, there is no study establishing correlations between the Expanded Disability Status Scale functional features and the impairments of the gait initiation.


Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: Motion Analysis

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients : Determination of Indicators of the Premature Degradation of the Orthostatic Posture, Gait Initiation and Walking
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : November 5, 2020
Estimated Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Multiple sclerosis patients
Analysis of orthostatic posture, initiation of walking and walking in MS patients with an EDSS between 0 and 4 (included) by a motion analysis system
Diagnostic Test: Motion Analysis
Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system

Healthy volunteers
Analysis of orthostatic posture, initiation of walking and walking in a group of healthy volunteers
Diagnostic Test: Motion Analysis
Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system




Primary Outcome Measures :
  1. Kinematics of lower limbs articulations [ Time Frame: at inclusion ]
    Kinematics of lower limbs will be performed by a motion analysis system. The analysis will be carried out with 4 infrared cameras, 2 force platforms, an electromyographic recording system, a computer system for signal analysis and data management. The optoelectronic system used is the 3D Vicon® system, which is based on passive stereovision. motive tasks (orthostatic posture, walking initiation, and the walking).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with an early-stage of MS (cases) versus healthy controls who do not have MS.
Criteria

Inclusion Criteria for MS patients :

  • EDSS < 4.5
  • Stable disease for at least 6 weeks
  • No injection of botulinum toxin in the past 4 months

no specific inclusion criteria for healthy volunteers

Exclusion Criteria for MS patients :

  • Neurological disease other than MS
  • Disabling pathologies of the locomotor apparatus
  • Non-stabilized Respiratory, Cardiovascular disease
  • Pregnant or breastfeeding women
  • Patient with cognitive impairment
  • Recent modification of MS treatment (<3 months)

Exclusion Criteria for Healthy Volunteers :

  • Neurological disease
  • Rheumatological disease
  • Sprain of the lower limbs in the last 3 months
  • Fracture of the lower limbs in the last year
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756142


Contacts
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Contact: Amélie Lansiaux, MD, PhD 3 20 22 52 69 ext 0033 lansiaux.amelie@ghicl.net
Contact: Jean-Jacques Vitagliano, PhD 3 20 22 57 51 ext 0033 vitagliano.jean-jacques@ghicl.net

Locations
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France
Hôpital Saint-Philibert Recruiting
Lomme, France, 59000
Contact: Caroline Massot, MD         
Principal Investigator: Caroline Massot, MD         
Sub-Investigator: Cécile Donzé, MD         
Sponsors and Collaborators
Lille Catholic University
Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines
Investigators
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Principal Investigator: Caroline Massot, MD GHICL
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03756142    
Other Study ID Numbers: RC-P0067
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
3D analysis
Biomarkers
Rehabilition
Locomotion
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases