Automated EDSS Score Calculation by Smartphone Application (Easy EDSS)

Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients

The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.

Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.

The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.

Study Overview

• Status: Completed
• Conditions: MS CHRONIC PROGRESSIVE
• Intervention / Treatment: Other: neurological exam

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- patients coming to the MS Competence and Recovery Centre

Description

Inclusion Criteria:

• Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination.
• Age ≥ 18 years
• No opposition to the use of their data

Exclusion Criteria:

- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Multiple Sclerosis

Other: neurological exam; Patients participating in the study are recruited from the investigator's tertiary multiple sclerosis management centre. They are systematically examined neurologically as part of their routine follow-up. the patient will be exceptionally examined by two distinct persons, a senior doctor and a junior doctor (internal or external) independently. At the end of the neurological examination, each examiner will evaluate the EDSS score in a classical way (using paper definitions) then using the smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EDSS score apllication VS paper version	comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18-PP-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No