Easy EDSS: Automated EDSS Score Calculation by Smartphone Application

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT03586635

Collaborator

(none)

105

Enrollment

Location

32.7

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
MS CHRONIC PROGRESSIVE	Other: neurological exam

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2018

Actual Primary Completion Date :

Dec 21, 2020

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

EDSS score apllication VS paper version [6 months]
comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT03586635

Other Study ID Numbers:

18-PP-09

First Posted:

Jul 13, 2018

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 18, 2022