Automated EDSS Score Calculation by Smartphone Application

MS CHRONIC PROGRESSIVE Clinical Trial

— Easy EDSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586635
• Other study ID #: 18-PP-09
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: September 3, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 3, 2021
• Est. primary completion date: December 21, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MS CHRONIC PROGRESSIVE

Intervention

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

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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