Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis (MARCHE)

September 7, 2016 updated by: Fondation Ophtalmologique Adolphe de Rothschild

35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.

This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

64

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

Ages Eligible for Study

14 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

35 patients with multiple sclerosis progressing for less than 5 years, age 18 to 54 years old, and handicap score (EDSS) < 2 in all the subscores concerning gait, have been enrolled in a previous observational study recording and analyzing gait parameters.

This study aims to enroll gender and aed matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.

The 35 patients have given their consent for this new data analysis.

Description

Inclusion Criteria:

  • subjects without any gait trouble
  • age ≥ 18 and < 55 years old
  • gender and age (+/- 5 years) matched

Exclusion Criteria:

  • pathology with potential gait impairment
  • pregnant or breast feeding patient
  • patient under legal protection
  • no health insurance coverage
  • absence of written informed consent

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
healthy control subjects
patients with multiple sclerosis
recruited in a former study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation coefficient of gait cadence
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Raphaël DEPAZ, MD, Fondation OPH A de Rothschild

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

Primary Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDZ_2014_17

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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