Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS) (FRENPRILS)

April 29, 2026 updated by: University Hospital, Tours

Validation of the French Version of the PLSFRS Scale

This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study conducted in 8 French ALS centers which will enroll 80 patients with PLS. All these patients will undergo an evaluation of their functional status from the ALSFRS-r and PLSFRS scales. All patients will be evaluated at 3 time points (T0,M6 at the outpatient clinic) and at M3 remotely. The aim of the study will be to validate a trans-cultural and psychometric version of the PLSFRS available for the French PLS population.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29000
        • University Hospital
      • Clermont-Ferrand, France, 63000
        • University Hospital
      • Lille, France, 59000
        • University Hospital
      • Limoges, France, 87000
        • University Hospital
      • Lyon, France, 69000
        • University Hospital
      • Nice, France, 05000
        • University Hospital
      • Tours, France, 37044
        • University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with primary lateral sclerosis

Description

Inclusion Criteria:

  • Patients with primary lateral sclerosis (PLS)
  • Age over 18 years
  • Informed consent signed
  • Patients cared in a French ALS centre

Exclusion Criteria:

  • patients with no oral and written command of the French language
  • Patients unable to answer a questionnaire
  • Opposition to data processing

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a primary lateral sclerosis
Other: Assessment of the functional status
assessment of their functional status using the French version of the PLSFRS scale during a routine multidisciplinary assessment every 3-6 months for all patients with motor neurone disease, as recommended by the FILSLAN network

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
French version of the PLSFRS scale
Time Frame: inclusion and 6 months
10 items with a score from 0 to 6; 2 items with a score from 0 to 4 Maximal score is 68.
inclusion and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Global Impression (CGI) scale
Time Frame: 6 months
overall clinical impression of the change; score from 1 to 7
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Philippe CORCIA, PR, University Hospital, Tours

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

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR240260-FRENPRILS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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