Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06878235

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital, Brest, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of the functional status

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change Global Impression (CGI) scale

    Time frame: 6 months

    overall clinical impression of the change; score from 1 to 7

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Validation of the French Version of the PLSFRS Scale

Acronym: FRENPRILS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.