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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dual TAsk
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • NeurologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DT patients

Arm Description

Outcomes

Primary Outcome Measures

Oscillation rate
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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
February 9, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT04090996
Brief Title
Effects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients
Acronym
MOCOGSEP
Official Title
Ffects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients With Low Level of Disability
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DT patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual TAsk
Intervention Description
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;
Primary Outcome Measure Information:
Title
Oscillation rate
Description
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
Time Frame
DAy 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Montcuquet, MD
Phone
0555058645
Email
a.montcuquet@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anaick Perrochon, PhD
Phone
+33 679723648
Email
anaick.perrochon@unilim.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Magy, MD
Organizational Affiliation
CHU Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurologie
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis MONTCUQUET, MD

12. IPD Sharing Statement

Learn more about this trial

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

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