Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients

NCT ID: NCT03756142

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2020-01-07

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Motion Analysis

Intervention Type: DIAGNOSTIC_TEST

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

Motion Analysis

Intervention Type: DIAGNOSTIC_TEST

Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system

Interventions

Motion Analysis

Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines

UNKNOWN

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Massot, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

Hôpital Saint-Philibert

Lomme, , France

Countries

France

Other Identifiers

RC-P0067

Identifier Type: -

Identifier Source: org_study_id