Multiple SclerosisWALKING-SEPNCT03756142
Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Motion Analysis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2018to 7 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an early-stage of MS (cases) versus healthy controls who do not have MS.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Motion Analysis
- Keywords
- 3D analysis, Biomarkers, Rehabilition, Locomotion
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion AnalysisDiagnostic test
Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Motion Analysis | |
| Healthy volunteers | Analysis of orthostatic posture, initiation of walking and walking in a group of healthy volunteers Receives: Diagnostic Test: Motion Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics of lower limbs articulations
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).
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start19 Nov 2018
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines
- Responsible party
- Sponsor
- Investigators
- Caroline Massot, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756142
- Sponsor's protocol ID
- RC-P0067
- Acronym
- WALKING-SEP
- Status last verified
- Mar 2024
- First submitted
- 26 Nov 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03756142
- Acronym / sponsor ID
- WALKING-SEP / RC-P0067
- Conditions
- Multiple Sclerosis
- Keywords
- 3D analysis, Biomarkers, Rehabilition, Locomotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | – | Diagnostic Test: Motion AnalysisAnalysis of orthostatic posture, initiation of walking and walking in MS patients with an EDSS between 0 and 4 (included) by a motion analysis system |
| Healthy volunteers | – | Diagnostic Test: Motion AnalysisAnalysis of orthostatic posture, initiation of walking and walking in a group of healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an early-stage of MS (cases) versus healthy controls who do not have MS.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Neurological disease other than MS
- Disabling pathologies of the locomotor apparatus
- Non-stabilized Respiratory, Cardiovascular disease
- Pregnant or breastfeeding women
- Patient with cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion AnalysisAnalysis of orthostatic posture, initiation of walking and walking by a motion analysis system | Diagnostic test | Healthy volunteers, Multiple sclerosis patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Massot, MD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics of lower limbs articulations (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.