Effects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients (MOCOGSEP)

February 9, 2021 updated by: University Hospital, Limoges

Ffects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients With Low Level of Disability

Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease affecting the central nervous system. It is the leading cause of severe non-traumatic disability in young adults (20-40 years). It affects more than 540,000 individuals in Europe and around 2.8 million people worldwide. The etiology of MS remains unknown to date, but probably results from a genetic predisposition associated with environmental factors (vitamin D deficiency, tobacco, vaccines, stress, diet, ...). MS is a neurological disease in which demyelination and axonal loss lead to many symptoms such as fatigue, spasticity, decreased sensitivity, muscle weakness, balance disorders, oculomotor visuals.

The Expanded Disability Status Scale (EDSS), which is used to rate functional disorders in MS patients, tends to underestimate these neurological disorders, which are often present in the early stages of the disease and are an important issue. major in the management and evolution of the disease.

Recently, it has been shown that motor and cognitive disorders appear in the early stages of the disease, yet these functions are not systematically evaluated in the early stages of the disease. These isolated or associated disorders often lead to real difficulties in realizing everyday activities. Since this disease affects young people who still have a professional activity, it is important not to underestimate the presence of these functional and cognitive disorders.

It is therefore necessary to seek more precise means of evaluation to detect certain neurological disorders.

Thus, the evaluation of these functions participates in the follow-up of the patient and makes it possible to better apprehend the evolution of these disorders in MS.

The investigators will use the concept of double-task to measure and evaluate these functional and cognitive disorders.

The dual task (DT) , is defined by the simultaneous completion of two tasks, one called "primary" and the other called "secondary", for which the performance changes are measured. The dual task paradigms are based on the assumption that two concurrently performed tasks interfere if they use identical functional and / or brain subsystems. In the case of a paradigm involving walking and another task, the interference is based on the assumption of the joint play of attention. The primary task is then the "attentional" task and the secondary task is represented by walking. Observed inferences are changes in the performance of one or both tasks that are measured by comparing single and dual task performance.

The assessment of DT's capabilities would improve the early detection of motor disorders in MS patients. Early identification of postural instability would make it easier to target care and improve patient follow-up. Conducting work on the concept of DT would improve our knowledge of this paradigm in MS.

Finally, a better understanding of double-stained mechanisms in MS could offer training programs

Study Overview

Status

Status

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

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 (Anticipated)

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.
20

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Limoges, France
        • Recruiting
        • Neurologie
        • Contact:
          • Alexis MONTCUQUET, MD

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient aged 18 to 65 years old;
  • relapsing-remitting MS (RR);
  • able to hold the station standing 180s without a device assistance;
  • Expanded Disability Status Scale <4;
  • able to give informed consent to participate in this study ;
  • without any push in the 60 days before the participation in this study (to be clinically stable);
  • no change in the treatment of MS since at least 2 month.

Exclusion Criteria:

  • acute illness other than MS during the past 60 days;
  • neurological and psychiatric diseases, except the SEP ;
  • orthopedic and rheumatological disorders that may affect the market ;
  • visual acuity <7/10 for the best eye after correction visual;
  • patient undergoing psychiatric care;

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: DT patients
Diagnostic test: Dual TAsk

Motor assessment includes:

  • posturographic examination in Single-task (ST) and Double-task (DT)
  • an analysis of ST and DT walking;
  • Timed Up and Go (TUG) performances in real (rTUG) and imagined (iTUG) versions;

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
Oscillation rate
Time Frame: DAy 1
The presence of postural instability is determined by a value of oscillation rate greater than 2 standard deviations from the mean of the healthy population used in this study
DAy 1

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.
University Hospital, Limoges

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: Laurent Magy, MD, CHU Limoges

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.
January 20, 2021

Primary Completion (Anticipated)

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.
April 20, 2022

Study Completion (Anticipated)

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 20, 2022

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).
September 13, 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.
September 13, 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.
September 16, 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.
February 11, 2021

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.
February 9, 2021

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.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • I16037 (MOCOGSEP)

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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